Skip to content

REMEDY Poly+Plus Tibial Spacer RPPSM17

by Osteoremedies, LLC

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 Number00850011453346 UDI-DI Date16 Dec 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  • Withdrawn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
REMEDY Poly+Plus Tibial Spacer
Generic Name
Uncoated unicondylar knee tibia prosthesis, polyethylene
Model / Ref / Catalog
RPPSM17
Primary DI / UDI-DI
00850011453346
510(k) Number
FDA Product Code
JWH
GMDN Term
Uncoated unicondylar knee tibia prosthesis, polyethylene
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242377)

Other devices from Osteoremedies, LLC

See all devices from Osteoremedies, LLC →

Properties

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

Other properties (9)

  • Implantable: No
  • 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