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Tmj System

FDA UDI

Class III (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
TMJ SYSTEM FDA UDI
Generic Name
Total temporomandibular joint prosthesis FDA UDI
Device Name
45MM RIGHT NARROW MANDIBULAR COMPONENT FDA UDI
Model / Reference
01-6545 FDA UDI
Description
45MM RIGHT NARROW MANDIBULAR COMPONENT FDA UDI

Identifiers

Catalog Number
01-6545 FDA UDI
Primary DI / UDI-DI
00841036011857 FDA UDI
PMA Number
P020016 FDA UDI
FDA Product Code
LZD FDA UDI
GMDN Term
Total temporomandibular joint prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
872.3940 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Total temporomandibular joint prosthesis

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

Similar devices

Also classified as Total temporomandibular joint prosthesis.

Cleared under the same submission

P020016 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 d37613ca-08e6-4b1c-9fe2-00da40f5957b 36 fields · synced May 30, 2026