Biomet Microfixation OmniMax MMF System— 510(k) K202969
Substantially EquivalentBiomet Microfixation
FDA 510(k) clearance K202969 for Biomet Microfixation OmniMax MMF System, Substantially Equivalent on 2021-08-05. Applicant: Biomet Microfixation. Device class: 2.
Clearance details
- Applicant
- Biomet Microfixation
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code JEY
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- K253206 — METICULY Patient-specific CMF solution
- K252246 — Leforte MMF System
- K253373 — Southern Craniomaxillofacial (CMF) System
- K251441 — Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System
More clearances from Biomet Microfixation
view allAdverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.