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® Stem Extension Component 150, 13/11 OD FDA UDI
Model / Reference: RSK150 FDA UDI
Description: REMEDY® Stem Extension Component 150, 13/11 OD FDA UDI

Identifiers

Catalog Number: RSK150 FDA UDI
Primary DI / UDI-DI: 00850011453230 FDA UDI
510(k) Number: K223650 FDA UDI
FDA Product Code: JWH FDA UDI
GMDN Term: Orthopaedic cement spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic cement spacer

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

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Also classified as Orthopaedic cement spacer.

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Bio-Modular Shoulder System — Biomet Orthopedics, Inc. · Class II
Interspace Knee ATS 80/07 — Tecres · Class II

Cleared under the same submission

K223650 also covers:

Remedy Spacer — OSTEOREMEDIES, LLC

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Osteoremedies, Llc

Sources (1)

FDA UDI 3a568be2-a9be-466f-95ed-7172f2ea3f53 35 fields · synced May 30, 2026