Orthopedic Salvage System (oss)

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: ORTHOPEDIC SALVAGE SYSTEM (OSS) FDA UDI
Generic Name: Coated knee tibia prosthesis FDA UDI
Model / Reference: CP102514 FDA UDI

Identifiers

Catalog Number: CP102514 FDA UDI
Primary DI / UDI-DI: 00880304018068 FDA UDI
510(k) Number: K002757 FDA UDI
K021260 FDA UDI
K051479 FDA UDI
K051570 FDA UDI
K060131 FDA UDI
K080330 FDA UDI
K123501 FDA UDI
K140509 FDA UDI
FDA Product Code: KRO FDA UDI
JDI FDA UDI
MEH FDA UDI
LZO FDA UDI
LPH FDA UDI
KWZ FDA UDI
KWY FDA UDI
KWT 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
888.3353 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
888.3390 FDA UDI
888.3650 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

FDA UDI

Category: Coated knee tibia prosthesis

Orthopedic Salvage System (oss) 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

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 51a5f3e9-3e7f-4985-b741-a41ac3ba8f11 36 fields · synced Jun 6, 2026