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., part of OrthofixLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Blackstone Medical with 45 510(k) clearances. The most recent is a 510(k) clearance dated Jul 28, 2010: FIREBIRD SPINAL FIXATION SYSTEM.
| Jul 28, 2010 | FIREBIRD SPINAL FIXATION SYSTEMK093926 · NKB | 510(k) clearances |
| May 4, 2010 | HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATESK100614 · KWQ | 510(k) clearances |
| Sep 25, 2009 | FIREBIRD SPINAL FIXATION SYSTEMK092624 · NKB | 510(k) clearances |
| Oct 17, 2008 | BLACKSTONE PEDICLE SCREW SYSTEMK082797 · NKB | 510(k) clearances |
| Sep 15, 2008 | BLACKSTONE PEDICLE SCREW SYSTEMK081684 · NKB | 510(k) clearances |
| Sep 4, 2008 | BLACKSTONE PILLAR XL PEEK SPACERSK082235 · MAX | 510(k) clearances |
| Aug 28, 2008 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICEK081849 · OVD | 510(k) clearances |
| Jul 23, 2008 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEMK081177 · 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
