Medtronic Sofamor Danek USA, Inc.
Medtronic Sofamor Danek USA, Inc. holds FDA 510(k) medical device clearances, first cleared 2000, most recent 2026, with 85 FDA device recalls on record.
Clearances by Medtronic Sofamor Danek USA, Inc. — page 2
101–173 of 173- K133577 — CLYDESDALE(R) SPINAL SYSTEM
- K141494 — CD HORIZON SPINAL SYSTEM
- K140750 — SHILLA GROWTH GUIDANCE SYSTEM
- K141605 — CD HORIZON SPINAL SYSTEM
- K140374 — MASTERGRAFT PUTTY
- K140454 — NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
- K133653 — ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
- K140375 — MASTERGRAFT PUTTY, MASTERGRAFT STRIP
- K133205 — CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
- K133645 — PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM
- K133650 — CAPSTONE SPINAL SYSTEM
- K132328 — CD HORIZON SPINAL SYSTEM
- K132584 — PERIMETER C SPINAL SYSTEM
- K132639 — CD HORIZON SPINAL SYSTEM
- K131669 — PERIMETER INTERBODY FUSION DEVICE
- K132471 — CD HORIZON SPINAL SYSTEM
- K131673 — MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
- K130177 — ANATOMIC PEEK CERVICAL FUSION SYSTEM
- K130640 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
- K130335 — MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
- K130646 — CD HORIZON SPINAL SYSTEM
- K123906 — VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
- K123656 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K123809 — CD HORIZON SPINAL SYSTEM
- K123270 — POWEREASE SYSTEM
- K123568 — VERTEX RECONSTRUCTION SYSTEM
- K122862 — CD HORIZON SPINAL SYSTEM
- K121760 — CAPSTONE SPINAL SYSTEM
- K121680 — CD HORIZON SPINAL SYSTEM
- K120271 — ARTISAN SPACE MAINTENANCE SYSTEM
- K120368 — CAPSTONE CONTROL SPINAL SYSTEM
- K113528 — CLYDESDALE(R) SPINAL SYSTEM
- K112405 — CLYDESDALES SPINAL SYSTEM
- K113174 — CD HORIZON SPINAL SYSTEM
- K112555 — CD HORIZON(R) SPINAL SYSTEM
- K111942 — TSRH SPINAL SYSTEMS
- K110543 — CRESCENT (R) SPINAL SYSTEM TITANIUM
- K100967 — PERIMETER C SPINAL SYSTEM
- K110259 — ARCHITEX SPACE MAINTENANCE SYSTEM
- K110522 — VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K100779 — SUSTAIN SPACE MAINTENANCE SYSTEM
- K102555 — CD HORIZON SPINAL SYSTEM
- K100976 — T2 XVBR 1.5 SPINAL SYSTEM
- K101074 — MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
- K092087 — MEDTRONIC DENTAL TCP
- K092325 — MODIFICATION TO:CD HORIZON SPINAL SYSTEM
- K091883 — T2 SPINAL SYSTEM
- K091974 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K082728 — VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
- K082732 — MODIFICATION TO: CAPSTONE SPINAL SYSTEM
- K073285 — PEEK PREVAIL CERVICAL INTERBODY DEVICE
- K080429 — MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
- K073291 — CAPSTONE SPINAL SYSTEM
- K071416 — PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
- K072317 — MODIFICATION TO:TSRH SPINAL SYSTEM
- K062986 — MEDTRONIC GRAFT DELIVERY SYRINGE
- K052261 — MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
- K051674 — CD HORIZON SPINAL SYSTEM
- K050809 — CD HORIZON SPINAL SYSTEM
- K050981 — CD HORIZON SPINAL SYSTEM
- K051039 — BASIS SPINAL SYSTEM
- K050079 — CD HORIZON SPINAL SYSTEM
- K041460 — CD HORIZON SPINAL SYSTEM
- K031655 — CD HORIZON SPINAL SYSTEM
- K021170 — TSRH SPINAL SYSTEM
- K012506 — MASTERGRAFT RESORBABLE CERAMIC GRANULES
- K010528 — TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
- K011443 — THREADED CEMENT RESTRICTOR (CR) TITANIUM
- K010701 — MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
- K010632 — BUTTERFLY PLATE FUNCTION SYSTEM
- K010529 — TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
- K002103 — SIMPLICITY SPINAL SYSTEM
- K000094 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.