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PointCloud Knee Instruments UKI0201-R

by Unik Orthopedics, Inc 217 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberTKRR0001B8520 UDI-DI Date5 May 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  • Withdrawn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
TKRR0001B8520
FDA Product Code
LLZ, OOG, MBH, JWH
GMDN Term
Total knee prosthesis implantation guide-instrument kit
Device Class
Class II
Regulation Number
892.2050, 888.3560, 888.3565
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