Stryker CMF MEDPOR Customized Implant
FDA 510(k) clearance K143173 · decided 2015-03-23
Clearance details
- K-number
- K143173
- Device name
- Stryker CMF MEDPOR Customized Implant
- Applicant
- Stryker
- Decision
- Substantially Equivalent
- Date received
- 2014-11-04
- Decision date
- 2015-03-23
- Days to decision
- 139 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Portage, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.