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Unity Total Knee System 1126216

by Corin Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05056139247934 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Unity Total Knee System
Generic Name
Tibial insert
Model / Ref / Catalog
1126216
Primary DI / UDI-DI
05056139247934
510(k) Number
FDA Product Code
OIY, JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241570)

Show all (12)

Other devices from Corin Ltd

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No