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 Shoulder Humeral Head 45mm FDA UDI
Model / Reference: RSHHMD FDA UDI
Description: Remedy Shoulder Humeral Head 45mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00855195006197 FDA UDI
FDA Product Code: KWS FDA UDI
GMDN Term: Orthopaedic cement spacer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

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

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 2142faa5-8720-44ae-9e71-b7108a95383f 33 fields · synced May 30, 2026