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Screw Extractor 110008497

by Biomet Orthopedics, Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868463280 UDI-DI Date23 Mar 2021ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0616-2021 FDA Class II initiated 25 Nov 2020

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Screw Extractor
Generic Name
Orthopaedic bone screw, non-bioabsorbable, sterile
Model / Ref / Catalog
110008497
Primary DI / UDI-DI
00887868463280
510(k) Number
FDA Product Code
HWC
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K143188)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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