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Comprehensive Instrumentation 110029132

by Biomet Orthopedics, Inc.

Comprehensive Instrumentation 110029132 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193373 on 15 Apr 2020 and listed in FDA GUDID since 8 May 2020 (UDI-DI 00880304731516), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K193373

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304731516 UDI-DI Date8 May 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193373 Date15 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193373 decided 15 Apr 2020 Active
  • FDA GUDID UDI-DI 00880304731516 listed 8 May 2020 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0619-2021 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.

    • Terminated Z-0093-2021 FDA Class II initiated 2 Sep 2020

    Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

Timeline

4 dated events

  1. Cleared FDA 510(k) K193373
  2. Listed FDA GUDID 00880304731516
  3. Recall initiated FDA recalls Z-0093-2021
  4. Recall initiated FDA recalls Z-0619-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Comprehensive Instrumentation
Generic name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
110029132
Primary DI / UDI-DI
00880304731516
510(k) Number
FDA product code
KWS, PHX
GMDN term
Orthopaedic implant impactor, reusable
Device class
Class II
Regulation number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant impactor, reusable

Cleared under the same submission (K193373)

and 8 more cleared under K193373

Similar devices in this category

Other devices filed under Orthopaedic implant impactor, reusable.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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