OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
FDA 510(k) clearance K133046 · decided 2014-05-14
Clearance details
- K-number
- K133046
- Device name
- OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
- Applicant
- Matrix Surgical Holdings, LLC/Matrix Surgical USA
- Decision
- Substantially Equivalent
- Date received
- 2013-09-27
- Decision date
- 2014-05-14
- Days to decision
- 229 days
- Clearance type
- Traditional
- Product code
- KKY
- Device class
- 2
- Regulation number
- 878.3500
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Alpharetta, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium recall (Z-1382-2017) | Matrix Surgical Holdings, LLC | 2017-02-28 |