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Comprehensive Reverse Shoulder Instrument

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
COMPREHENSIVE REVERSE SHOULDER INSTRUMENT FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Model / Reference
406207 FDA UDI

Identifiers

Catalog Number
406207 FDA UDI
Primary DI / UDI-DI
00880304532335 FDA UDI
510(k) Number
K120121 FDA UDI
K132239 FDA UDI
K193373 FDA UDI
FDA Product Code
KWS FDA UDI
PHX FDA UDI
GMDN Term
Surgical drill guide, reusable 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

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

Similar devices

Also classified as Surgical drill guide, reusable.

Cleared under the same submission

K120121 also covers:

K132239 also covers:

K193373 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 bcb3567e-7833-4d13-8e31-d56c7b54af56 36 fields · synced Jun 6, 2026