The following data is part of a premarket notification filed by Additive Orthopaedics, Llc with the FDA for Additive Orthopaedics Patient Specific 3d Printed Bone Segments.
| Device ID | K180239 |
| 510k Number | K180239 |
| Device Name: | Additive Orthopaedics Patient Specific 3D Printed Bone Segments |
| Classification | Plate, Fixation, Bone |
| Applicant | Additive Orthopaedics, LLC 83 Amelia Circle Little Silver, NJ 07739 |
| Contact | Gregory Kowalczyk |
| Correspondent | Gregory 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 | 2018-01-29 |
| Decision Date | 2018-05-16 |
| Summary: | summary |