OSS™ Orthopedic Salvage System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: OSS™ Orthopedic Salvage System FDA UDI
Generic Name: Diaphysis prosthesis FDA UDI
Model / Reference: 161078 FDA UDI

Identifiers

Catalog Number: 161078 FDA UDI
Primary DI / UDI-DI: 00880304475755 FDA UDI
510(k) Number: K052685 FDA UDI
K123501 FDA UDI
FDA Product Code: JDI FDA UDI
KRO FDA UDI
JWH FDA UDI
GMDN Term: Diaphysis prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
888.3510 FDA UDI
888.3560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Category: Diaphysis prosthesis

OSS™ Orthopedic Salvage System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diaphysis prosthesis.

OsteoBridge™ Interlocking Screw — Merete GmbH · Class II
OsteoBridge™ IDSF Diaphysis Humeral Nail — Merete GmbH · Class II
OsteoBridge™ IDSF Diaphysis Tibial Nail — Merete GmbH · Class I
OsteoBridge™ — Merete GmbH · Class I
OsteoBridge™ IDSF Diaphysis Femoral Spacer — Merete GmbH · Class II
OsteoBridge™ IDSF Diaphysis Tibial Nail — Merete GmbH · Class II
OsteoBridge™ IDSF Diaphysis Femoral Nail — Merete GmbH · Class II
Megasystem C — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI f849c3d8-abad-43cd-9d3a-f5c34dab8ecd 36 fields · synced May 30, 2026