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Remedy Spacer

FDA UDI

Class II (US FDA UDI)

by Osteoremedies, Llc

Identity

Trade Name
Remedy Spacer FDA UDI
Generic Name
Orthopaedic cement spacer FDA UDI
Device Name
REMEDY® Acetabular Cup 40mm ID/48mm OD FDA UDI
Model / Reference
RHACXS FDA UDI
Description
REMEDY® Acetabular Cup 40mm ID/48mm OD FDA UDI

Identifiers

Catalog Number
RHACXS FDA UDI
Primary DI / UDI-DI
00850011453087 FDA UDI
510(k) Number
K192995 FDA UDI
FDA Product Code
KWL FDA UDI
KWY FDA UDI
GMDN Term
Orthopaedic cement spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
888.3390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic cement spacer

Remedy Spacer by Osteoremedies, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic cement spacer.

Cleared under the same submission

K192995 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Osteoremedies, Llc

Sources (1)

  • FDA UDI bc138546-7eea-4086-a302-212e67922057 35 fields · synced May 31, 2026