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"
169–192 of 435
Search insights Median review: 66d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Feb 09, 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB
Medtronic Sofamor Danek
Orthopedic · 71d
Cleared Feb 06, 2012
PERIMETER INTERBODY FUSION DEVICE
K113642 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 56d
Cleared Jan 17, 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · OVE
Medtronic Sofamor Danek
Orthopedic · 75d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Nov 21, 2011
CD HORIZON SPINAL SYSTEM
K113174 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 91d
Cleared Nov 09, 2011
TELAMON PEEK SPINAL SYSTEM
K110562 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 254d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 12, 2011
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
K111264 · ODP
Medtronic Sofamor Danek USA
Orthopedic · 161d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · NKB
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
Cleared Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · MAX
Medtronic Sofamor Danek
Orthopedic · 208d
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676 · NKB
Medtronic Sofamor Danek
Orthopedic · 74d
Cleared Apr 13, 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 75d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049 · NKB
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Dec 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 269d