Comprehensive® Reverse Shoulder

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Comprehensive® Reverse Shoulder FDA UDI
Generic Name: Shoulder prosthesis screw FDA UDI
Model / Reference: 180562 FDA UDI

Identifiers

Catalog Number: 180562 FDA UDI
Primary DI / UDI-DI: 00880304677296 FDA UDI
510(k) Number: K080642 FDA UDI
K130390 FDA UDI
K132239 FDA UDI
FDA Product Code: PAO FDA UDI
KWS FDA UDI
MBF FDA UDI
PHX FDA UDI
KWT FDA UDI
GMDN Term: Shoulder prosthesis screw FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Shoulder prosthesis screw

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

Similar devices

Also classified as Shoulder prosthesis screw.

Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Humelock II Cementless Shoulder System — FX SOLUTIONS · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
Glenoid Reconstruction System — Medacta International · Class II
Glenoid Reconstruction System — Medacta International · 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

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

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI a56ce1df-ef7d-4acd-9b48-96bfad6b7bba 36 fields · synced Jun 6, 2026