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Identity CR KA 3DP Porous 5253-0011

by Restor3D

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840097536750 UDI-DI Date25 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Identity CR KA 3DP Porous
Generic Name
Total knee prosthesis implantation guide-instrument kit
Model / Ref / Catalog
5253-0011, TCR-000-SPEC
Primary DI / UDI-DI
00840097536750
510(k) Number
FDA Product Code
MBH, JWH, OIY, OOG
GMDN Term
Total knee prosthesis implantation guide-instrument kit
Device Class
Class II
Regulation Number
888.3565, 888.3560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K243768)

Show all (12)

Other devices from Restor3D

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Manufacturing Date: No