Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

175 results for "Medtronic Sofamor Danek USA, Inc."
97–120 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Jan 21, 2015
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
K141599 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 222d
Cleared Dec 04, 2014
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
K141632 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 169d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K143141 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 01, 2014
CD HORIZON Spinal System
K142591 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 77d
Cleared Oct 21, 2014
CD HORIZON SPINAL SYSTEM
K141604 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 127d
Cleared Oct 01, 2014
DIVERGENCE Anterior Cervical Fusion System
K142450 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 26, 2014
CLYDESDALE(R) SPINAL SYSTEM
K133577 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 309d
Cleared Aug 06, 2014
CD HORIZON SPINAL SYSTEM
K141494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 61d
Cleared Jul 17, 2014
SHILLA GROWTH GUIDANCE SYSTEM
K140750 · PGM
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jul 14, 2014
CD HORIZON SPINAL SYSTEM
K141605 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
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 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
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 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 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 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d