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PointCloud Knee Instruments UKI0201-L

by Unik Orthopedics, Inc 193 variants

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 NumberTKRL00018K2B0 UDI-DI Date4 Oct 2025ListedStatusListed 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  • Withdrawn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
PointCloud Knee Instruments
Generic Name
Total knee prosthesis implantation guide-instrument kit
Model / Reference
UKI0201-L
Primary DI / UDI-DI
TKRL00018K2B0
510(k) Number
FDA Product Code
OOG, MBH, JWH
GMDN Term
Total knee prosthesis implantation guide-instrument kit
Device Class
Class II
Regulation Number
888.3560, 888.3565
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K240327)

Show all (12)

Other devices from Unik Orthopedics, Inc

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Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

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