The following data is part of a premarket notification filed by Additive Orthopaedics, Llc with the FDA for Additive Orthopaedics Locking Lattice Plate.
| Device ID | K170214 |
| 510k Number | K170214 |
| Device Name: | Additive Orthopaedics Locking Lattice Plate |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-24 |
| Decision Date | 2017-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005508489 | K170214 | 000 |
| 00850005508472 | K170214 | 000 |
| 00850005508465 | K170214 | 000 |
| 00850005508458 | K170214 | 000 |
| 00850005508441 | K170214 | 000 |
| 00850005508434 | K170214 | 000 |
| 00850005508427 | K170214 | 000 |
| 00850005508410 | K170214 | 000 |
| 00850005508403 | K170214 | 000 |