Blackstone Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: FIREBIRD SPINAL FIXATION SYSTEM, HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES, FIREBIRD SPINAL FIXATION SYSTEM
45
Total
45
Cleared
0
Denied
FDA 510(k) Regulatory Record - Blackstone Medical, Inc. Orthopedic ✕
45 devices
Cleared
Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
Orthopedic
218d
Cleared
May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
Orthopedic
61d
Cleared
Sep 25, 2009
FIREBIRD SPINAL FIXATION SYSTEM
Orthopedic
30d
Cleared
Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
Orthopedic
24d
Cleared
Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
Orthopedic
90d
Cleared
Sep 04, 2008
BLACKSTONE PILLAR XL PEEK SPACERS
Orthopedic
28d
Cleared
Aug 28, 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
Orthopedic
59d
Cleared
Jul 23, 2008
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
Orthopedic
89d
Cleared
Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
Orthopedic
29d
Cleared
Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
Orthopedic
28d
Cleared
Feb 14, 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
Orthopedic
71d
Cleared
Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
Orthopedic
29d
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