Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Additive Orthopaedics with 7 510(k) clearances. The most recent is a 510(k) clearance dated Jun 28, 2022: Patient Specific Marking Guides.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 28, 2022 | Patient Specific Marking GuidesK211076 · PBF | 510(k) clearances |
| Jan 10, 2019 | Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesK183011 · HRS | 510(k) clearances |
| May 16, 2018 | Additive Orthopaedics Patient Specific 3D Printed Bone SegmentsK180239 · HRS | 510(k) clearances |
| Jun 20, 2017 | Additive Orthopaedics Bunion SystemK163593 · HRS | 510(k) clearances |
| Apr 13, 2017 | Additive Orthopaedics Locking Lattice PlateK170214 · HRS | 510(k) clearances |
| Sep 7, 2016 | Additive Orthopaedics Bone Wedge SystemK153207 · HRS | 510(k) clearances |
| Jun 1, 2016 | Additive Orthopaedics Hammertoe Correction SystemK160264 · HTY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
