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Bio-Modular Shoulder System 113794

by Biomet Orthopedics, Inc.

Bio-Modular Shoulder System 113794 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K032507 on 5 Sep 2003 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304213760), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304213760 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK032507 Date5 Sep 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032507 decided 5 Sep 2003 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00880304213760 listed 24 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K872454
  2. Cleared FDA 510(k) K032507
  3. Listed FDA GUDID 00880304213760

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bio-Modular Shoulder System
Generic name
Orthopaedic cement spacer
Model / Ref / Catalog
113794
Primary DI / UDI-DI
00880304213760
510(k) Number
FDA product code
KWS, KWT, HSD
GMDN term
Orthopaedic cement spacer
Device class
Class II
Regulation number
888.3660, 888.3650, 888.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthopaedic cement spacer

Cleared under the same submission (K032507)

and 6 more cleared under K032507

Cleared under the same submission (K872454)

and 8 more cleared under K872454

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)