Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
FDA 510(k) K162124 · DePuy Synthes
510(k) numberK162124
Submission
- Device name
- Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
- Applicant
- DePuy Synthes
West Chester, PA, US - Received
- August 1, 2016
- Decision date
- March 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDP – Condylar Plate Fixation Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110354 | 4.5MM Va-Lcp Curved Condylar Plate SystemJDP · Special | Synthes USA | 03/04/2011SE |
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Questions and answers
When was Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins cleared by the FDA?
Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins (K162124) received a 510(k) decision of Substantially Equivalent on March 29, 2017, 240 days after the submission was received.
What is the product code of K162124?
The FDA product code is JDP – Condylar Plate Fixation Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.