# Blackstone Medical, Inc.

- Location (FDA's records): Springfield, MA
- FDA decisions: 45 (1997–2010): 45 510(k) clearances
- Product codes: KWQ (13), KWP (7), MNI (7), MQP (6), NKB (4), MNH (3), MAX (2), HRX (1), NQW (1), OVD (1)
- Predicates its devices cite: 138 (94 its own); citations of its devices by later devices: 203 (94 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Synthes (Usa): 6 (https://510kreport.com/company/synthes-usa)
- Synthes Spine: 5 (https://510kreport.com/company/synthes-spine)
- Medtronic Sofamor Danek: 5 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Depuy, Inc.: 3 (https://510kreport.com/company/depuy)
- Depuy Spine, Inc.: 3 (https://510kreport.com/company/depuy-spine)
- Surgicraft, Ltd.: 3 (https://510kreport.com/company/surgicraft)

## Firms that cite its devices most
- Orthofix, Inc.: 30 (https://510kreport.com/company/orthofix)
- Orthofix US, LLC: 5 (https://510kreport.com/company/orthofix-us)
- Neurostructures, Inc.: 5 (https://510kreport.com/company/neurostructures)
- Ulrich GmbH & Co. KG: 4 (https://510kreport.com/company/ulrich)
- Lanx, Inc.: 4 (https://510kreport.com/company/lanx)
- Life Spine, Inc.: 4 (https://510kreport.com/company/life-spine)
- Blackstone: 4 (https://510kreport.com/company/blackstone)
- Icotec AG: 3 (https://510kreport.com/company/icotec)

## Its most-cited devices
- K030197: Blackstone Posterior Cervical System (2003), cited by 12
- K974885: Blackstone Medical Inc. Anterior Cervical Plate System (1998), cited by 10
- K994217: Blackstone Spinal Fixation System (2000), cited by 10
- K082797: Blackstone Pedicle Screw System (2008), cited by 9
- K012184: Blackstone Iii Anterior Cervical Plating System (2002), cited by 9
- K023498: Modification to Blackstone Spinal Fixation System (2002), cited by 8

## Recent decisions
- K093926: Firebird Spinal Fixation System (Jul 28, 2010)
- K100614: Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates (May 4, 2010)
- K092624: Firebird Spinal Fixation System (Sep 25, 2009)
- K082797: Blackstone Pedicle Screw System (Oct 17, 2008)
- K081684: Blackstone Pedicle Screw System (Sep 15, 2008)
- K082235: Blackstone Pillar XL Peek Spacers (Sep 4, 2008)
- K081849: Blackstone Pillar SA Partial Vertebral Body Replacement Device (Aug 28, 2008)
- K081177: Blackstone Medical, Inc., Pillar Spacer System (Jul 23, 2008)

Source page: https://510kreport.com/company/blackstone-medical