Medical Device Manufacturer · US , Springfield , MA

Blackstone Medical, Inc. - FDA 510(k) Cleared Devices

45 submissions · 45 cleared · Since 1997
45
Total
45
Cleared
0
Denied
FDA 510(k) Regulatory Record - Blackstone Medical, Inc. Orthopedic ✕
45 devices
1-12 of 45
Cleared Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · NKB
Orthopedic · 218d
Cleared May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · KWQ
Orthopedic · 61d
Cleared Sep 25, 2009
FIREBIRD SPINAL FIXATION SYSTEM
K092624 · NKB
Orthopedic · 30d
Cleared Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797 · NKB
Orthopedic · 24d
Cleared Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · NKB
Orthopedic · 90d
Cleared Sep 04, 2008
BLACKSTONE PILLAR XL PEEK SPACERS
K082235 · MAX
Orthopedic · 28d
Cleared Aug 28, 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · OVD
Orthopedic · 59d
Cleared Jul 23, 2008
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K081177 · MAX
Orthopedic · 89d
Cleared Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394 · KWP
Orthopedic · 29d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · MNI
Orthopedic · 28d
Cleared Feb 14, 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420 · KWP
Orthopedic · 71d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · KWP
Orthopedic · 29d

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