SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
FDA 510(k) clearance K131186 · decided 2013-10-08
Clearance details
- K-number
- K131186
- Device name
- SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
- Applicant
- Synthes (USA) Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-04-25
- Decision date
- 2013-10-08
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.