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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
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Model / Reference
151828 FDA UDI

Identifiers

Catalog Number
151828 FDA UDI
Primary DI / UDI-DI
00880304674646 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
K141331 FDA UDI
K142814 FDA UDI
FDA Product Code
LPH FDA UDI
KRO FDA UDI
JDI FDA UDI
MEH FDA UDI
LZO FDA UDI
KWY FDA UDI
KWZ FDA UDI
KWT FDA UDI
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3358 FDA UDI
888.3510 FDA UDI
888.3350 FDA UDI
888.3353 FDA UDI
888.3390 FDA UDI
888.3310 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone screw, non-bioabsorbable, sterile

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 Orthopaedic bone screw, non-bioabsorbable, sterile.

Cleared under the same submission

K002757 also covers:

K021260 also covers:

K051479 also covers:

K051570 also covers:

K060131 also covers:

K080330 also covers:

K123501 also covers:

K140509 also covers:

K141331 also covers:

K142814 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 81574705-e1cf-4d77-8ec8-819824ef389d 36 fields · synced May 30, 2026