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

435 results for "Medtronic Sofamor Danek"
121–144 of 435
Search insights Median review: 66d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Jun 10, 2014
MASTERGRAFT PUTTY
K140374 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 116d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Apr 28, 2014
ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
K133653 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 152d
Cleared Apr 18, 2014
MASTERGRAFT PUTTY, MASTERGRAFT STRIP
K140375 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Mar 25, 2014
CD HORIZON SPINAL SYSTEM
K140449 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Mar 13, 2014
CD HORIZON SPINAL SYSTEM
K140276 · OSH
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Feb 25, 2014
CD HORIZON SPINAL SYSTEM GROWTH ROD SET
K133904 · PGM
Medtronic Sofamor Danek USA
Orthopedic · 67d
Cleared Jan 03, 2014
PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM,...
K133645 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Dec 20, 2013
CAPSTONE SPINAL SYSTEM
K133650 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Dec 06, 2013
CD HORIZON SPINAL SYSTEM
K132328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 04, 2013
PERIMETER C SPINAL SYSTEM
K132584 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 110d
Cleared Nov 25, 2013
CD HORIZON SPINAL SYSTEM
K132639 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Nov 01, 2013
PERIMETER INTERBODY FUSION DEVICE
K131669 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 147d
Cleared Oct 08, 2013
CD HORIZON SPINAL SYSTEM
K132471 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 62d
Cleared Oct 03, 2013
MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
K131673 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 118d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jun 05, 2013
CD HORIZON SPINAL SYSTEM
K131321 · OSH
Medtronic Sofamor Danek USA
Orthopedic · 28d