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REMEDY Poly+Plus Acetabular Cup RHPAC40

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 Number00850011453506 UDI-DI Date1 Jun 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  • Withdrawn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
REMEDY Poly+Plus Acetabular Cup
Generic Name
Orthopaedic cement spacer
Model / Ref / Catalog
RHPAC40
Primary DI / UDI-DI
00850011453506
510(k) Number
FDA Product Code
KWL, KWY
GMDN Term
Orthopaedic cement spacer
Device Class
Class II
Regulation Number
888.3360, 888.3390
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K253675)

Other devices from Osteoremedies, LLC

See all devices from Osteoremedies, LLC →

Properties

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

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No