← Back to catalogue

Comprehensive Reverse Shoulder

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
Comprehensive Reverse Shoulder FDA UDI
Generic Name
Polyethylene reverse shoulder prosthesis cup FDA UDI
Model / Reference
EP-115394 FDA UDI

Identifiers

Catalog Number
EP-115394 FDA UDI
Primary DI / UDI-DI
00880304543188 FDA UDI
510(k) Number
K080642 FDA UDI
K113121 FDA UDI
K193373 FDA UDI
FDA Product Code
KWS FDA UDI
PAO FDA UDI
PHX FDA UDI
GMDN Term
Polyethylene reverse shoulder prosthesis cup 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: Polyethylene reverse shoulder prosthesis cup

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

Similar devices

Also classified as Polyethylene reverse shoulder prosthesis cup.

Cleared under the same submission

K080642 also covers:

K113121 also covers:

K193373 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI b3abb939-ab03-4402-986d-79704cde726b 36 fields · synced Jun 7, 2026