OmniPore DUROMAX Surgical Implants
FDA 510(k) clearance K180249 · decided 2018-10-11
Clearance details
- K-number
- K180249
- Device name
- OmniPore DUROMAX Surgical Implants
- Applicant
- Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Decision
- Substantially Equivalent
- Date received
- 2018-01-29
- Decision date
- 2018-10-11
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- JEY
- Device class
- 2
- Regulation number
- 872.4760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Atlanta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.