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Comprehensive Instrumentation 405800

by Biomet Orthopedics, Inc.

Comprehensive Instrumentation 405800 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K193373 on 15 Apr 2020 (1 earlier submission) and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00880304469594), active as of 23 Oct 2026. 3 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

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193373 Date15 Apr 2020DecidedStatusActive
United StatesGUDID listing Number00880304469594 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193373 decided 15 Apr 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304469594 listed 28 Jul 2017 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1131-2021 FDA Class II initiated 15 Jan 2021

    Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

    • 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

6 dated events

  1. Cleared FDA 510(k) K132239
  2. Listed FDA GUDID 00880304469594
  3. Cleared FDA 510(k) K193373
  4. Recall initiated FDA recalls Z-0093-2021
  5. Recall initiated FDA recalls Z-0619-2021
  6. Recall initiated FDA recalls Z-1131-2021

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  • Withdrawn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 bone wire
Model / Ref / Catalog
405800
Primary DI / UDI-DI
00880304469594
510(k) Number
FDA product code
PHX, KWS, HWT, PAO, FZX
GMDN term
Orthopaedic bone wire
Device class
Class II
Regulation number
888.3660, 888.4800, 878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic bone wire

Cleared under the same submission (K132239)

and 8 more cleared under K132239

Cleared under the same submission (K193373)

and 8 more cleared under K193373

Similar devices in this category

Other devices filed under Orthopaedic bone wire.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)