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Inhance 5100-26-522

by Depuy (Ireland)

Inhance 5100-26-522 (510026522) is a Class II device made by Depuy (Ireland), cleared under FDA 510(k) K212933 on 8 Jun 2022 and listed in FDA GUDID since 28 Feb 2023 (UDI-DI 10603295549154), 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

510(k) K212933

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 Number10603295549154 UDI-DI Date28 Feb 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK212933 Date8 Jun 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K212933 decided 8 Jun 2022 Active
  • FDA GUDID UDI-DI 10603295549154 listed 28 Feb 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K212933
  2. Listed FDA GUDID 10603295549154

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inhance
Generic name
Shoulder glenoid fossa prosthesis, prefabricated
Model / Ref / Catalog
5100-26-522, 510026522
Primary DI / UDI-DI
10603295549154
510(k) Number
FDA product code
KWS, PAO, MBF, HSD, KWT
GMDN term
Shoulder glenoid fossa prosthesis, prefabricated
Device class
Class II
Regulation number
888.3660, 888.3670, 888.3690, 888.3650
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Shoulder glenoid fossa prosthesis, prefabricated

Cleared under the same submission (K212933)

Similar devices in this category

Other devices filed under Shoulder glenoid fossa prosthesis, prefabricated.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)