The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes Hammertoe Continuous Compression Implant.
| Device ID | K191463 |
| 510k Number | K191463 |
| Device Name: | DePuy Synthes Hammertoe Continuous Compression Implant |
| Classification | Staple, Fixation, Bone |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Keith Knapp |
| Correspondent | Keith Knapp Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-03 |
| Decision Date | 2020-02-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810633022054 | K191463 | 000 |
| 00810633022047 | K191463 | 000 |