The following data is part of a premarket notification filed by Additive Orthopaedics, Llc with the FDA for Additive Orthopaedics Bone Wedge System.
| Device ID | K153207 |
| 510k Number | K153207 |
| Device Name: | Additive Orthopaedics Bone Wedge System |
| 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 | 2015-11-05 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850005508175 | K153207 | 000 |
| 00850005508250 | K153207 | 000 |
| 00850005508243 | K153207 | 000 |
| 00850005508236 | K153207 | 000 |
| 00850005508229 | K153207 | 000 |
| 00850005508397 | K153207 | 000 |
| 00850005508380 | K153207 | 000 |
| 00850005508373 | K153207 | 000 |
| 00850005508366 | K153207 | 000 |
| 00850005508359 | K153207 | 000 |
| 00850005508342 | K153207 | 000 |
| 00850005508335 | K153207 | 000 |
| 00850005508328 | K153207 | 000 |
| 00850005508311 | K153207 | 000 |
| 00850005508304 | K153207 | 000 |
| 00850005508298 | K153207 | 000 |
| 00850005508281 | K153207 | 000 |
| 00850005508267 | K153207 | 000 |
| 00850005508274 | K153207 | 000 |
| 00850005508007 | K153207 | 000 |
| 00850005508168 | K153207 | 000 |
| 00850005508151 | K153207 | 000 |
| 00850005508144 | K153207 | 000 |
| 00850005508137 | K153207 | 000 |
| 00850005508120 | K153207 | 000 |
| 00850005508113 | K153207 | 000 |
| 00850005508106 | K153207 | 000 |
| 00850005508090 | K153207 | 000 |
| 00850005508083 | K153207 | 000 |
| 00850005508076 | K153207 | 000 |
| 00850005508069 | K153207 | 000 |
| 00850005508052 | K153207 | 000 |
| 00850005508045 | K153207 | 000 |
| 00850005508038 | K153207 | 000 |
| 00850005508021 | K153207 | 000 |
| 00850005508014 | K153207 | 000 |
| 00889795120199 | K153207 | 000 |