Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Osseus Fusion Systems and its 1 subsidiaries with 13 510(k) clearances. The most recent is a 510(k) clearance dated Aug 21, 2026: Pisces-SC Standalone Cervical Interbody System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Osseus Fusion Systems and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 21, 2026 | Pisces-SC Standalone Cervical Interbody SystemK261882 · OVE | 510(k) clearances |
| Feb 10, 2023 | Pisces™-SA STANDALONE ALIF Interbody SystemK223413 · OVD | 510(k) clearances |
| Nov 3, 2022 | Black Diamond™ POCT Spinal SystemK222107 · NKG | 510(k) clearances |
| May 6, 2022 | PISCES-SA Standalone ALIF Interbody SystemK213935 · OVD | 510(k) clearances |
| Mar 1, 2022 | Blue Topaz Sacroiliac Screw SystemK213590 · OUR | 510(k) clearances |
| Jan 17, 2020 | Black Diamond Navigation InstrumentsK192495 · OLO | 510(k) clearances |
| Oct 29, 2019 | Black Diamond Pedicle Screw SystemK192121 · NKB | 510(k) clearances |
| Aug 15, 2018 | Aries® Lumbar InterbodiesK181347 · MAX | 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
