510(k) K162124
- Device
- Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
- Applicant
- DePuy Synthes
- 510(k) number
- K162124
- Product code
- JDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-03-29
- Date received
- 2016-08-01
- Regulation
- 888.3030
- Classification name
- Condylar Plate Fixation Implant
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER J. MEDBERRY
- Address
- 1301 Goshen Pkwy. West Chester PA US 19380 19380
FDA Registration Numbers#
- 8043792
- 3010363503
- 3000270450
- 3043620689
- 3034676720
- 3009417901
- 3015876273
- 3015440604
- 3015399803
- 3008812560
- 3015869493
- 3013756169
- 1526534
- 3008868758
Source Documents#
Other 510(k) Records For Product Code JDP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K110354 | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM | Synthes USA | 2011-03-04 |
Legacy Summary#
summary
FDA Review#
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