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Comprehensive Shoulder System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
COMPREHENSIVE SHOULDER SYSTEM FDA UDI
Generic Name
Humeral stem prosthesis trial, reusable FDA UDI
Model / Reference
405315 FDA UDI

Identifiers

Catalog Number
405315 FDA UDI
Primary DI / UDI-DI
00880304560949 FDA UDI
510(k) Number
K060692 FDA UDI
K080642 FDA UDI
K193038 FDA UDI
FDA Product Code
KWS FDA UDI
PAO FDA UDI
HSD FDA UDI
KWT FDA UDI
MBF FDA UDI
GMDN Term
Humeral stem prosthesis trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3690 FDA UDI
888.3650 FDA UDI
888.3670 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Humeral stem prosthesis trial, reusable

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

Similar devices

Also classified as Humeral stem prosthesis trial, reusable.

Cleared under the same submission

K060692 also covers:

K080642 also covers:

K193038 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 45c11867-86b6-4d86-abd3-f59aba9855fa 36 fields · synced May 30, 2026