Biomet Microfixation OmniMax MMF System

Q: What is the product code of K202969?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.

FDA 510(k) K202969 · Biomet Microfixation

Substantially Equivalent

510(k) numberK202969

Submission

Device name: Biomet Microfixation OmniMax MMF System
Applicant: Biomet Microfixation
Jacksonville, FL, US
Received: September 30, 2020
Decision date: August 5, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JEY – Plate, Bone
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.4760
Specialty: Dental
Implant: Yes

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Questions and answers

When was Biomet Microfixation OmniMax MMF System cleared by the FDA?

Biomet Microfixation OmniMax MMF System (K202969) received a 510(k) decision of Substantially Equivalent on August 5, 2021, 309 days after the submission was received.

What is the product code of K202969?

The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.