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Selex® Modular Head Trial S063136

by Biomet Orthopedics, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304163539 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1143-2012 FDA Not yet classified initiated 7 Feb 2012

    Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.

    • Terminated Z-1449-2012 FDA Unclassified (pre-2012) initiated 13 Sep 2011

    Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Selex® Modular Head Trial
Generic Name
Femoral head prosthesis trial
Model / Ref / Catalog
S063136
Primary DI / UDI-DI
00880304163539
510(k) Number
FDA Product Code
LZO
GMDN Term
Femoral head prosthesis trial
Device Class
Class II
Regulation Number
888.3353
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Femoral head prosthesis trial

Cleared under the same submission (K062997)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No