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."
25–45 of 45
Search insights Median review: 61d Cleared: 100% Top manufacturer: Blackstone Medical, Inc. Lead specialty: Orthopedic
Cleared Oct 09, 2003
BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS
K032700 · MQP
Blackstone Medical, Inc.
Orthopedic · 37d
Cleared Jun 27, 2003
BLACKSTONE SURGICAL TITANIUM MESH
K030744 · MQP
Blackstone Medical, Inc.
Orthopedic · 109d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · KWP
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Apr 24, 2003
BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM
K030595 · KWQ
Blackstone Medical, Inc.
Orthopedic · 58d
Cleared Apr 17, 2003
BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR
K030862 · MNI
Blackstone Medical, Inc.
Orthopedic · 30d
Cleared Mar 28, 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · KWQ
Blackstone Medical, Inc.
Orthopedic · 203d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · KWP
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Aug 21, 2002
BLACKSTONE SPINAL FIXATION SYSTEM STAPLE & WASHER
K022605 · KWQ
Blackstone Medical, Inc.
Orthopedic · 15d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared May 23, 2002
BLACKSTONE III DEGREE ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020620 · KWQ
Blackstone Medical, Inc.
Orthopedic · 87d
Cleared May 22, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER)
K020600 · KWQ
Blackstone Medical, Inc.
Orthopedic · 89d
Cleared Apr 03, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW
K020674 · MNH
Blackstone Medical, Inc.
Orthopedic · 33d
Cleared Feb 01, 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · MNI
Blackstone Medical, Inc.
Orthopedic · 70d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · KWQ
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · KWQ
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · MNH
Blackstone Medical, Inc.
Orthopedic · 75d
Cleared Jun 17, 1998
BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM
K974885 · KWQ
Blackstone Medical, Inc.
Orthopedic · 169d
Cleared Sep 25, 1997
BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM
K972768 · HRX
Blackstone Medical, Inc.
Orthopedic · 63d