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PointCloud Knee Instruments UKI0201-R

by Unik Orthopedics, Inc 277 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberTKRR0001LKI30 UDI-DI Date20 Oct 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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-R
Primary DI / UDI-DI
TKRR0001LKI30
FDA Product Code
OOG, MBH, JWH, LLZ
GMDN Term
Total knee prosthesis implantation guide-instrument kit
Device Class
Class II
Regulation Number
888.3560, 888.3565, 892.2050
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Unik Orthopedics, Inc

See all devices from Unik Orthopedics, Inc →

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