K180239 is an FDA 510(k) clearance for the Additive Orthopaedics Patient Specific 3D Printed Bone Segments. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Additive Orthopaedics, LLC (Little Silver, US). The FDA issued a Cleared decision on May 16, 2018, 107 days after receiving the submission on January 29, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K180239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2018 |
| Decision Date | May 16, 2018 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS - Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |