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Affinity J (Instruments for Microscope) 0903312

by Medtronic Sofamor Danek, Inc.

Affinity J (Instruments for Microscope) 0903312 is a Class I device made by Medtronic Sofamor Danek, Inc., listed in FDA GUDID since 17 Oct 2022 (UDI-DI 00885074084558), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885074084558 UDI-DI Date17 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Affinity J (Instruments for Microscope)
Generic name
Orthopaedic broach
Model / reference
0903312
Description
REAMER 0903312 12MM
Primary DI / UDI-DI
00885074084558
FDA product code
HTO
GMDN term
Orthopaedic broach
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic broach

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Other devices filed under Orthopaedic broach.

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Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)