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Identity™ SAHTST12

by Zimmer, Inc.

Identity™ SAHTST12 is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K213856 on 15 Sep 2022 and listed in FDA GUDID since 27 Sep 2022 (UDI-DI 00889024627451), active as of 22 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 22 Oct 2026

Documents

510(k) K213856

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024627451 UDI-DI Date27 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213856 Date15 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213856 decided 15 Sep 2022 Active
  • FDA GUDID UDI-DI 00889024627451 listed 27 Sep 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K213856
  2. Listed FDA GUDID 00889024627451

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Identity™
Generic name
Reverse shoulder prosthesis body
Model / Ref / Catalog
SAHTST12
Primary DI / UDI-DI
00889024627451
510(k) Number
FDA product code
KWT, MBF, KWS, HSD, PHX
GMDN term
Reverse shoulder prosthesis body
Device class
Class II
Regulation number
888.3650, 888.3670, 888.3660, 888.3690
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

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Properties

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