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Tsp Hip Fx Plating Systemguide Wire Depth Gauge, 3.0mm 14-451525

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887868130076 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-1347-2020 FDA Class II initiated 7 Jan 2020

    Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

    • Terminated Z-2240-2016 FDA Class II initiated 10 Jun 2016

    The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tsp Hip Fx Plating Systemguide Wire Depth Gauge, 3.0mm
Generic Name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
14-451525
Primary DI / UDI-DI
00887868130076
510(k) Number
FDA Product Code
KTT, JDO
GMDN Term
Fluted surgical drill bit, single-use
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Fluted surgical drill bit, single-use

Cleared under the same submission (K140018)

Show all (12)

Other devices from Biomet Orthopedics, Inc.

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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