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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
Skin/tissue hook FDA UDI
Model / Reference
010001827 FDA UDI

Identifiers

Catalog Number
010001827 FDA UDI
Primary DI / UDI-DI
00880304538740 FDA UDI
510(k) Number
K080642 FDA UDI
FDA Product Code
PAO FDA UDI
KWS FDA UDI
GMDN Term
Skin/tissue hook 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

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Skin/tissue hook

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

Similar devices

Also classified as Skin/tissue hook.

Cleared under the same submission

K080642 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 94c74029-1cfa-4e56-8cce-603f580e00ca 35 fields · synced Jun 1, 2026