Compress Device

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: COMPRESS DEVICE FDA UDI
Generic Name: Coated shoulder humeral stem prosthesis FDA UDI
Model / Reference: 178759 FDA UDI

Identifiers

Catalog Number: 178759 FDA UDI
Primary DI / UDI-DI: 00880304554870 FDA UDI
510(k) Number: K112905 FDA UDI
K123297 FDA UDI
K173411 FDA UDI
K183553 FDA UDI
FDA Product Code: KWT FDA UDI
JDC FDA UDI
MBF FDA UDI
KWS FDA UDI
KWY FDA UDI
LPH FDA UDI
JDI FDA UDI
KRO FDA UDI
MEH FDA UDI
KWZ FDA UDI
LZO FDA UDI
PHX FDA UDI
GMDN Term: Coated shoulder humeral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3650 FDA UDI
888.3150 FDA UDI
888.3670 FDA UDI
888.3660 FDA UDI
888.3390 FDA UDI
888.3358 FDA UDI
888.3350 FDA UDI
888.3510 FDA UDI
888.3353 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

FDA UDI

Category: Coated shoulder humeral stem prosthesis

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

Similar devices

Also classified as Coated shoulder humeral stem prosthesis.

OsseoFit™ Stemless Shoulder — Zimmer, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Tornier HRS — TORNIER, INC. · Class II
Trabecular Metal® — Zimmer, Inc. · Class II
INHANCE — DEPUY (IRELAND) · Class II
Aequalis™ PerFORM+ — TORNIER, INC. · Class II
Trabecular Metal® — Zimmer, Inc. · Class II
Tornier Perform® Anatomic Augmented Glenoid — TORNIER, 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 0a08db75-6c48-4aee-8a80-d4516d4e05a9 36 fields · synced May 30, 2026