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Cmf System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
CMF SYSTEM FDA UDI
Generic Name
Implantable craniofacial bone distractor FDA UDI
Model / Reference
SP-1885 FDA UDI

Identifiers

Catalog Number
SP-1885 FDA UDI
Primary DI / UDI-DI
00841036150525 FDA UDI
510(k) Number
K992952 FDA UDI
FDA Product Code
MQN FDA UDI
GMDN Term
Implantable craniofacial bone distractor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Cmf System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K992952 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI e1d2dccf-5f09-4274-ab90-9563824a155e 36 fields · synced Jun 1, 2026