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Off Axis Comp Mini Reamer 6-Spoke Lg

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
OFF AXIS COMP MINI REAMER 6-SPOKE LG FDA UDI
Generic Name
Glenoid orthopaedic reamer FDA UDI
Model / Reference
SSI007412 FDA UDI

Identifiers

Catalog Number
SSI007412 FDA UDI
Primary DI / UDI-DI
00889024661172 FDA UDI
510(k) Number
K172502 FDA UDI
FDA Product Code
KWS FDA UDI
KWT FDA UDI
MBF FDA UDI
PAO FDA UDI
PHX FDA UDI
GMDN Term
Glenoid orthopaedic reamer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 FDA UDI
888.3650 FDA UDI
888.3670 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: Glenoid orthopaedic reamer

Off Axis Comp Mini Reamer 6-Spoke Lg by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glenoid orthopaedic reamer.

Cleared under the same submission

K172502 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 f9b87e36-18d1-41a0-9ea8-7ab9e4f9be3f 36 fields · synced May 30, 2026