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Comprehensive Reverse Shoulder

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
Comprehensive Reverse Shoulder FDA UDI
Generic Name
Reverse shoulder prosthesis body FDA UDI
Model / Reference
115331 FDA UDI

Identifiers

Catalog Number
115331 FDA UDI
Primary DI / UDI-DI
00880304554283 FDA UDI
510(k) Number
K080642 FDA UDI
K120121 FDA UDI
K193373 FDA UDI
K992367 FDA UDI
FDA Product Code
KWS FDA UDI
PHX FDA UDI
GMDN Term
Reverse shoulder prosthesis body FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 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

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: Reverse shoulder prosthesis body

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

Similar devices

Also classified as Reverse shoulder prosthesis body.

Cleared under the same submission

K080642 also covers:

K120121 also covers:

K193373 also covers:

K992367 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 937891d8-6b94-43f2-b767-35c35dfccd55 36 fields · synced May 30, 2026