The following data is part of a premarket notification filed by Additive Orthopaedics, Llc with the FDA for Additive Orthopaedics Hammertoe Correction System.
| Device ID | K160264 |
| 510k Number | K160264 |
| Device Name: | Additive Orthopaedics Hammertoe Correction System |
| Classification | Pin, Fixation, Smooth |
| Applicant | Additive Orthopaedics, LLC 83 Amelia Circle Little Silver, NJ 07739 |
| Contact | Greg Kowalczyk |
| Correspondent | Greg Kowalczyk Additive Orthopaedics, LLC 83 Amelia Circle Little Silver, NJ 07739 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005508212 | K160264 | 000 |
| 00850005508205 | K160264 | 000 |
| 00850005508199 | K160264 | 000 |
| 00850005508182 | K160264 | 000 |