Compress Device

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: COMPRESS DEVICE FDA UDI
Generic Name: Body femoral/tibial extension stem, coated FDA UDI
Model / Reference: 178440 FDA UDI

Identifiers

Catalog Number: 178440 FDA UDI
Primary DI / UDI-DI: 00880304260085 FDA UDI
510(k) Number: K031804 FDA UDI
K043547 FDA UDI
FDA Product Code: KWY FDA UDI
LPH FDA UDI
KWZ FDA UDI
LZO FDA UDI
KRO FDA UDI
JDI FDA UDI
MEH FDA UDI
GMDN Term: Body femoral/tibial extension stem, coated FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3358 FDA UDI
888.3310 FDA UDI
888.3353 FDA UDI
888.3510 FDA UDI
888.3350 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: Body femoral/tibial extension stem, coated

Compress Device by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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COMPRESS DEVICE — Biomet Orthopedics, Inc. · Class II
COMPRESS DEVICE — Biomet Orthopedics, Inc. · Class II
Compress Device — Biomet Orthopedics, Inc. · 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 8ffdcb58-75ee-4266-8be3-14cc13351f2f 36 fields · synced Jun 6, 2026