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Comprehensive Shoulder 110005281

by Biomet Orthopedics, Inc.

Comprehensive Shoulder 110005281 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K130390 on 9 Oct 2013 and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 00880304568112), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K130390

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 Number00880304568112 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK130390 Date9 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K130390 decided 9 Oct 2013 Active
  • FDA GUDID UDI-DI 00880304568112 listed 28 Oct 2016 Listed

Recalls

1 recall · 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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K130390
  2. Listed FDA GUDID 00880304568112
  3. 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  • Withdrawn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 Shoulder
Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Model / Ref / Catalog
110005281
Primary DI / UDI-DI
00880304568112
510(k) Number
FDA product code
PHX, KWS, MBF, KWT, PAO
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class II
Regulation number
888.3660, 888.3670, 888.3650
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic implant-instrument extension adaptor, reusable

Cleared under the same submission (K130390)

and 8 more cleared under K130390

Similar devices in this category

Other devices filed under Orthopaedic implant-instrument extension adaptor, 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)