4.5MM Va-Lcp Curved Condylar Plate System
FDA 510(k) K110354 · Synthes USA
510(k) numberK110354
Submission
- Device name
- 4.5MM Va-Lcp Curved Condylar Plate System
- Applicant
- Synthes USA
West Chester, PA, US - Received
- February 7, 2011
- Decision date
- March 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…JDP · Traditional | DePuy Synthes | 03/29/2017SE |
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Questions and answers
When was 4.5MM Va-Lcp Curved Condylar Plate System cleared by the FDA?
4.5MM Va-Lcp Curved Condylar Plate System (K110354) received a 510(k) decision of Substantially Equivalent on March 4, 2011, 25 days after the submission was received.
What is the product code of K110354?
The FDA product code is JDP – Condylar Plate Fixation Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.