EUDAMED update: Nov 11, 2024

Integrity Implants Inc.

US-MF-000009805

Active236 devices

Address: Hiatt Drive, 354 34418 Palm Beach Gardens
Role: Manufacturer
Date of registration: Jul 14, 2021
Country: United States

Integrity Implants Inc. is a medical device manufacturer registered in EUDAMED. The company has 236 devices on the EU market across 6 countries. Headquartered in Palm Beach Gardens, United States. Explore the regulatory profile, devices and certificates on MD Atlas.

About Accelus

: US-MF-000009805
Role: Manufacturer
Country: United States
Organization name: Integrity Implants Inc.
EU VAT number: Not applicable
Date of registration: Jul 14, 2021

Contact details for Accelus

Phone: +1 561 529 3861
Email: internationalcs@accelusinc.com
Website: www.accelusinc.com
Address: 354, HIATT DRIVE 34418 PALM BEACH GARDENS UNITED STATES

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Competent authority

Name: DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover

Phone: -
Email: poststelle@gaa-h.niedersachsen.de

Officers and regulatory representatives of Accelus

GIAQUINTA Natalia
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, except that Lauren Kamer is responsible for verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices. Lauren Kamer is also responsible for clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF.
Hidden
HAMILTON Nancy
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10) and d) the reporting obligations referred to in Articles 87 to 91 are fulfilled, except that Lauren Kamer is responsible for update of clinical evaluations including PMCF.
Hidden
KAMER Lauren
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
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Connected operators

Importers

1 EU importer places this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
0 Degree Shaver and Distractor Tray	0 Degree Shaver and Distractor Tray	`ASY-00419`	`00810004728318`	1	On the market
9° and 15° Distractor Tray	9° and 15° Distractor Tray	`ASY-00420`	`00810004728332`	1	On the market
Ancillary Instrument Tray, FH7	Ancillary Instrument Tray, FH7	`ASY-00523`	`00810004729155`	1	On the market
Backup Fixed T-Handle	Backup Fixed T-Handle	`II-1-0372`	`00818613020182`	1	On the market
Depth Stop, FH7	Depth Stop, FH7	`ASY-00903`	`00840200405652`	1	On the market
Dilator Handle, FH7 MIS	Dilator Handle, FH7 MIS	`ASY-00481`	`00810004728851`	1	On the market
Dilator Impactor, FH7 ENDO	Dilator Impactor, FH7 ENDO	`CMP-01431`	`00810004729773`	1	On the market
Dilator Impactor, FH7 MIS	Dilator Impactor, FH7 MIS	`CMP-00480`	`00810004722002`	1	On the market
ENDO Access Tray, FH7	ENDO Access Tray, FH7	`ASY-00581`	`00810045538969`	1	On the market
Expandable Trial Insert Tray, FH7	Expandable Trial Insert Tray, FH7	`ASY-00653`	`00840200402811`	1	On the market
Fixed Hudson T-Handle	Fixed Hudson T-Handle	`II-1-0328`	`00818613020083`	1	On the market
Fixed Small Inline Handle	Fixed Small Inline Handle	`CMP-01023`	`00810004728134`	1	On the market
Fixed Small Teardrop Handle	Fixed Small Teardrop Handle	`CMP-01024`	`00810004728141`	1	On the market
FlareHawk Guide Pin Tray	FlareHawk Guide Pin Tray	`ASY-00857`	`00840200405324`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00113`	`00810004722286`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00132`	`00810004721906`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00120`	`00810004721838`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00121`	`00810004721876`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00122`	`00810004721869`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00656`	`00840200403139`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00116`	`00818613027594`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00255`	`00810004722309`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`FHTPS20630S`	`00810004721647`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`CMP-01738`	`00840200403085`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`FHTAS40027X`	`00810004723627`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
0 Degree Shaver and Distractor Tray	0 Degree Shaver and Distractor Tray	`ASY-00419`	`00810004728318`	1	On the market
9° and 15° Distractor Tray	9° and 15° Distractor Tray	`ASY-00420`	`00810004728332`	1	On the market
Ancillary Instrument Tray, FH7	Ancillary Instrument Tray, FH7	`ASY-00523`	`00810004729155`	1	On the market
Backup Fixed T-Handle	Backup Fixed T-Handle	`II-1-0372`	`00818613020182`	1	On the market
Depth Stop, FH7	Depth Stop, FH7	`ASY-00903`	`00840200405652`	1	On the market
Dilator Handle, FH7 MIS	Dilator Handle, FH7 MIS	`ASY-00481`	`00810004728851`	1	On the market
Dilator Impactor, FH7 ENDO	Dilator Impactor, FH7 ENDO	`CMP-01431`	`00810004729773`	1	On the market
Dilator Impactor, FH7 MIS	Dilator Impactor, FH7 MIS	`CMP-00480`	`00810004722002`	1	On the market
ENDO Access Tray, FH7	ENDO Access Tray, FH7	`ASY-00581`	`00810045538969`	1	On the market
Expandable Trial Insert Tray, FH7	Expandable Trial Insert Tray, FH7	`ASY-00653`	`00840200402811`	1	On the market
Fixed Hudson T-Handle	Fixed Hudson T-Handle	`II-1-0328`	`00818613020083`	1	On the market
Fixed Small Inline Handle	Fixed Small Inline Handle	`CMP-01023`	`00810004728134`	1	On the market
Fixed Small Teardrop Handle	Fixed Small Teardrop Handle	`CMP-01024`	`00810004728141`	1	On the market
FlareHawk Guide Pin Tray	FlareHawk Guide Pin Tray	`ASY-00857`	`00840200405324`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00113`	`00810004722286`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00132`	`00810004721906`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00120`	`00810004721838`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00121`	`00810004721876`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00122`	`00810004721869`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00656`	`00840200403139`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00116`	`00818613027594`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`ASY-00255`	`00810004722309`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`FHTPS20630S`	`00810004721647`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`CMP-01738`	`00840200403085`	1	On the market
FlareHawk Interbody Fusion System	FlareHawk Interbody Fusion System	`FHTAS40027X`	`00810004723627`	1	On the market

Integrity Implants Inc.

About Accelus

Contact details for Accelus

Export the 236 devices of Accelus

Competent authority

Officers and regulatory representatives of Accelus

Connected operators

Importers

Related searches

About Accelus

Contact details for Accelus

Export the 236 devices of Accelus

Competent authority

Officers and regulatory representatives of Accelus

Statistics for Accelus

Certificate health for Accelus

Devices by risk class

Market presence of Accelus

Device catalog for Accelus

Device families (Basic UDI-DI) of Accelus

Connected operators

Importers

Related searches

Certificate health for Accelus

Statistics for Accelus

Market presence of Accelus

Devices by risk class

Device catalog for Accelus

Device families (Basic UDI-DI) of Accelus