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: Coated knee tibia prosthesis FDA UDI
Model / Reference: 150443 FDA UDI

Identifiers

Catalog Number: 150443 FDA UDI
Primary DI / UDI-DI: 00880304239647 FDA UDI
510(k) Number: K002757 FDA UDI
K052685 FDA UDI
K083827 FDA UDI
FDA Product Code: KRO FDA UDI
JDI FDA UDI
LPH FDA UDI
LZO FDA UDI
KWY FDA UDI
KWT FDA UDI
MEH FDA UDI
KWZ FDA UDI
GMDN Term: Coated knee tibia prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
888.3350 FDA UDI
888.3358 FDA UDI
888.3353 FDA UDI
888.3390 FDA UDI
888.3650 FDA UDI
888.3310 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: Coated knee tibia 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 Coated knee tibia prosthesis.

ADVANTIM® — MicroPort Orthopedics Inc. · Class II
Consensus Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Natural-Knee® — Zimmer, Inc. · Class II
Balanced Knee System — ORTHO DEVELOPMENT CORP. · Class II
OMNI Knee — OMNIlife science, Inc. · Class II
Columbus® CR/PS — AESCULAP, INC. · Class II
ADVANTIM® — MicroPort Orthopedics Inc. · Class II
JOURNEY — Smith & Nephew, Inc. · Class I

Cleared under the same submission

K083827 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 02145358-6a71-4449-a029-31c792401501 36 fields · synced May 31, 2026