The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes 2.4/2.7mm Va Lcp Two-column Volar Distal Radius Plate, Extra-long.
| Device ID | K163046 |
| 510k Number | K163046 |
| Device Name: | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY SYNTHES 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Joanna Rieder |
| Correspondent | Joanna Rieder DEPUY SYNTHES 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612334110756 | K163046 | 000 |
| 07612334110855 | K163046 | 000 |
| 07612334110848 | K163046 | 000 |
| 07612334110831 | K163046 | 000 |
| 07612334110824 | K163046 | 000 |
| 07612334110817 | K163046 | 000 |
| 07612334110800 | K163046 | 000 |
| 07612334110794 | K163046 | 000 |
| 07612334110787 | K163046 | 000 |
| 07612334110862 | K163046 | 000 |
| 07612334110664 | K163046 | 000 |
| 07612334110749 | K163046 | 000 |
| 07612334110732 | K163046 | 000 |
| 07612334110725 | K163046 | 000 |
| 07612334110718 | K163046 | 000 |
| 07612334110701 | K163046 | 000 |
| 07612334110695 | K163046 | 000 |
| 07612334110688 | K163046 | 000 |
| 07612334110671 | K163046 | 000 |
| 07612334110770 | K163046 | 000 |