Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
FDA 510(k) clearance K162124 · decided 2017-03-29
Clearance details
- K-number
- K162124
- Device name
- Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
- Applicant
- DePuy Synthes
- Decision
- Substantially Equivalent
- Date received
- 2016-08-01
- Decision date
- 2017-03-29
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- JDP
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM (K110354) | Synthes USA | 2011-03-04 |
Recalls involving this device
No recalls on record reference this clearance.