Additive Orthopaedics, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K211076 | Patient Specific Marking Guides | June 28, 2022 |
| K183011 | Additive Orthopaedics Patient Specific 3D Locking Lattice Plates | January 10, 2019 |
| K180239 | Additive Orthopaedics Patient Specific 3D Printed Bone Segments | May 16, 2018 |
| K163593 | Additive Orthopaedics Bunion System | June 20, 2017 |
| K170214 | Additive Orthopaedics Locking Lattice Plate | April 13, 2017 |
| K153207 | Additive Orthopaedics Bone Wedge System | September 7, 2016 |
| K160264 | Additive Orthopaedics Hammertoe Correction System | June 1, 2016 |