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2.0mm Locking Fracture System

FDA UDI

Class II (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
2.0MM LOCKING FRACTURE SYSTEM FDA UDI
Generic Name
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI
Model / Reference
20-4504 FDA UDI

Identifiers

Catalog Number
20-4504 FDA UDI
Primary DI / UDI-DI
00841036069414 FDA UDI
510(k) Number
K113512 FDA UDI
K980512 FDA UDI
FDA Product Code
HWC FDA UDI
JEY FDA UDI
GMDN Term
Craniofacial fixation plate, non-bioabsorbable, non-customized FDA UDI

Classification

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

2.0mm Locking Fracture 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

K113512 also covers:

K980512 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 a97e34d2-8972-4e1f-a3ae-6c847d7b34c8 35 fields · synced May 30, 2026