Comprehensive(r) Shoulder System

FDA UDI

Class I (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: COMPREHENSIVE(R) SHOULDER SYSTEM FDA UDI
Generic Name: Bone approximation clamp FDA UDI
Model / Reference: 406994 FDA UDI

Identifiers

Catalog Number: 406994 FDA UDI
Primary DI / UDI-DI: 00880304009592 FDA UDI
FDA Product Code: GDJ FDA UDI
GMDN Term: Bone approximation clamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone approximation clamp

Comprehensive(r) Shoulder System by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Sklar® — Sklar Corporation · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Symmetry Martin — SYMMETRY SURGICAL INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 4fac6c5a-1b89-4f54-ae5b-9d05cc2f63cd 34 fields · synced May 30, 2026