FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

45 results for "Blackstone Medical, Inc."
1–24 of 45
Search insights Median review: 61d Cleared: 100% Top manufacturer: Blackstone Medical, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2010
FIREBIRD SPINAL FIXATION SYSTEM
K093926 · NKB
Blackstone Medical, Inc.
Orthopedic · 218d
Cleared May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · KWQ
Blackstone Medical, Inc.
Orthopedic · 61d
Cleared Sep 25, 2009
FIREBIRD SPINAL FIXATION SYSTEM
K092624 · NKB
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797 · NKB
Blackstone Medical, Inc.
Orthopedic · 24d
Cleared Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · NKB
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Sep 04, 2008
BLACKSTONE PILLAR XL PEEK SPACERS
K082235 · MAX
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Aug 28, 2008
BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
K081849 · OVD
Blackstone Medical, Inc.
Orthopedic · 59d
Cleared Jul 23, 2008
BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM
K081177 · MAX
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · MNI
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 14, 2008
BLACKSTONE ASCENT MULTIAXIAL SCREWS
K073420 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Jan 24, 2008
BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR
K073654 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jul 24, 2006
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · KWQ
Blackstone Medical, Inc.
Orthopedic · 83d
Cleared Feb 24, 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · MQP
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Jun 14, 2005
CONSTRUX MINI PEEK VBR SYSTEM
K051246 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Jun 14, 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · KWQ
Blackstone Medical, Inc.
Orthopedic · 173d
Cleared May 11, 2005
HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM
K050892 · KWQ
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Feb 18, 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · NQW
Blackstone Medical, Inc.
Orthopedic · 77d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · MNI
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Sep 20, 2004
BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR
K042100 · MNI
Blackstone Medical, Inc.
Orthopedic · 47d
Cleared Aug 17, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS
K041939 · MQP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · MQP
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · MNI
Blackstone Medical, Inc.
Orthopedic · 34d