← Back to catalogue

TraumaOne SYSTEM

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
TraumaOne SYSTEM FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Model / Reference
44-1002 FDA UDI

Identifiers

Catalog Number
44-1002 FDA UDI
Primary DI / UDI-DI
00888233008914 FDA UDI
510(k) Number
K063052 FDA UDI
K081067 FDA UDI
K113512 FDA UDI
FDA Product Code
JEY FDA UDI
HWC FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4760 FDA UDI
888.3040 FDA UDI
Commercial Distribution
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

Category: Craniofacial fixation plate, non-bioabsorbable, non-customized

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

Similar devices

Also classified as Craniofacial fixation plate, non-bioabsorbable, non-customized.

Cleared under the same submission

K063052 also covers:

K081067 also covers:

K113512 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI d92bf0ec-c5b8-44c1-8e50-bce28f76e770 35 fields · synced May 30, 2026