Pioneer Surgical Technology Inc.

Certificate MDR 751413

Rev. R001Supplemented

Valid until: Nov 23, 2027

Certificate MDR 751413 is a valid Quality management system issued to Pioneer Surgical Technology Inc. and registered in EUDAMED. Valid until November 23, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 751413
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 751413R001

Validity

Issued: Jun 5, 2026
Valid from: Jun 5, 2026
Valid until: Nov 23, 2027

Manufacturer

Manufacturer: Pioneer Surgical Technology Inc.
Manufacturer SRN: US-MF-000010369
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

MDR 751413SupplementedFeb 2, 2026 → Nov 23, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2Class I2Class IIa1

5 scopes

Bone fixation wires
Class IIb
Reusable Instruments ‘Orthopaedic Instruments’
Class I
Orthopaedic instruments connected to active device, non-sterile
Class IIa
Bone fixation plates
Class IIb
Reusable Instruments ‘General Surgery Instruments’
Class I

Documents

LanguagesEN