Biotech Sterile Hip Endoprosthesis Systems

Organization name

Biotech GmbH

SRN

DE-MF-000023586

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Hungary; available across 7 countries total.

Trade name

Biotech Sterile Hip Endoprosthesis Systems

UDI-DI code

D-4049852HI1CQSA

Basic UDI-DI

B-4049852HI1CQSA

Reference / catalog number

4049852HI1CQ

Issuing entity

EUDAMED

Risk category

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Biotech Sterile Hip Endoprosthesis Systems is a non-active surgical implant system for hip joint replacement. It is a modular device with several elements. It has a cemented or cementless design with device-specific accessories. It's a long-term, implantable device in class III. The device elements are made of metal (CoCr alloy, titanium alloy, stainless steel), plastic (UHMWPE) and ceramic raw materials.

Additional information URL

https://biotech-medical.com/bio/

Clinical sizes

• In this device group a huge number of devices are included with different sizes. All devices with all their exact names, sizes, reference numbers will attached to the documents in an xml file. — 0 MU50

• P090803010101PRIMARY IMPLANT CEMENTED METAL ACETABULAR CUPS
• P090803010102PRIMARY IMPLANT CEMENTED POLYETHYLENE ACETABULAR CUPS, ONE-PIECE
• P090803010199PRIMARY IMPLANT CEMENTED ACETABULAR CUPS - OTHER
• P090803010201PRIMARY IMPLANT UNCEMENTED METAL ACETABULAR CUPS
• P090803010202PRIMARY IMPLANT UNCEMENTED ONE-PIECE POLYETHYLENE ACETABULAR CUPS
• P090803010203PRIMARY IMPLANT UNCEMENTED ONE-PIECE METAL ACETABULAR CUPS
• P090803010299PRIMARY IMPLANT UNCEMENTED ACETABULAR CUPS - OTHER
• P09080302HIP RESURFACING ACETABULAR COMPONENTS
• P0908030301REVISION SURGERY CEMENTED ACETABULAR CUPS
• P0908030302REVISION SURGERY UNCEMENTED ACETABULAR CUPS
• P090803040101STANDARD POLYETHYLENE HIP PROSTHESES INSERTS
• P090803040102ECCENTRIC POLYETHYLENE HIP PROSTHESES INSERTS
• P090803040103RETENTIVE POLYETHYLENE HIP PROSTHESES INSERTS, ANTI-DISLOCATION
• P0908030402HIP PROSTHESES CERAMIC ACETABULAR INSERTS
• P0908030403HIP PROSTHESES METAL ACETABULAR INSERTS
• P0908030499HIP PROSTHESES ACETABULAR INSERTS - OTHER
• P090803050101CEMENTED DOUBLE-MOBILITY ACETABULAR CUPS
• P090803050102UNCEMENTED DOUBLE-MOBILITY ACETABULAR CUPS
• P0908030502DOUBLE-MOBILITY ACETABULAR COMPONENTS INSERTS
• P0908030601PRE-ASSEMBLED ACETABULAR COMPONENTS WITH CERAMIC INSERT
• P0908030602PRE-ASSEMBLED ACETABULAR COMPONENTS WITH POLYETHYLENE INSERTS
• P0908030699PRE-ASSEMBLED ACETABULAR COMPONENTS - OTHER
• P090804010101CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT
• P090804010102CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL
• P090804010105CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, FOR PRESERVATION
• P090804010106CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, STRAIGHT
• P090804010107CEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, ANATOMICAL
• P090804010201UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, STRAIGHT
• P090804010202UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, ANATOMICAL
• P090804010205UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH FIXED NECK, FOR PRESERVATION
• P090804010206UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, STRAIGHT
• P090804010207UNCEMENTED FEMORAL STEMS FOR PRIMARY IMPLANT, WITH MODULAR NECK, ANATOMICAL
• P09080402HIP RESURFACING FEMORAL COMPONENTS
• P090804030101REVISION CEMENTED FEMORAL STEMS, WITH FIXED NECK
• P090804030102REVISION CEMENTED FEMORAL STEMS, WITH MODULAR NECK
• P090804030201REVISION UNCEMENTED FEMORAL STEMS, WITH FIXED NECK
• P090804030202REVISION UNCEMENTED FEMORAL STEMS, WITH MODULAR NECK
• P09080404LARGE RESECTIONS FEMORAL STEMS
• P090804050101CERAMIC FEMORAL HEADS, PARTIAL HIP REPLACEMENT
• P090804050102METAL FEMORAL HEADS, PARTIAL HIP REPLACEMENT
• P090804050199FEMORAL HEADS FOR PRIMARY IMPLANT OF PARTIAL PROSTHESES - OTHER
• P090804050201CERAMIC FEMORAL HEADS, TOTAL HIP REPLACEMENT
• P090804050202METAL FEMORAL HEADS, TOTAL HIP REPLACEMENT
• P090804050299FEMORAL HEADS FOR PRIMARY IMPLANT OF TOTAL PROSTHESES - OTHER
• P0908040503HIP PROSTHESES, BI-ARTICULAR CUPS
• P0908040504REVISION FEMORAL HEADS
• P09080406ONE-PIECE FEMORAL PROSTHESES (STEM+HEAD)
• P09080407MODULAR NECKS
• P090805HIP PROSTHESES SPACERS
• P090899HIP PROSTHESES - OTHER

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• Serial number
• Software identification