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 |