HSA · registration DE0508546

Medtronic Sofamor Danek VERTEX™ Reconstruction system

Name: Medtronic Sofamor Danek VERTEX™ Reconstruction system — HSA DE0508546
Creator: Medtronic Sofamor Danek USA, Inc.
Keywords: Medtronic Sofamor Danek VERTEX™ Reconstruction system, Medtronic Sofamor Danek VERTEX™ Reconstruction system, DE0508546, Orthopaedics, HSA

SingaporeOrthopaedicsClass CMedtronic Sofamor Danek USA, Inc.

Verified

Official record identity

Registration number: DE0508546
Model name: ROD CONNECTOR, 3.2mm to 4.5mm; THREADED ROD; THREADED ROD; THREADED ROD; OCCIPITAL KEEL PLATE - SMALL; OCCIPITAL KEEL PLATE - MEDIUM; OCCIPITAL KEEL PLATE - LARGE; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; CORTICAL SCREW; LATERAL OFFSET CONNECTOR - OPEN; LATERAL OFFSET CONNECTOR - OPEN; LAMINAR HOOK; LAMINAR HOOK; OFFSET LAMINAR HOOK, LEFT; OFFSET LAMINAR HOOK, RIGHT; OFFSET LAMINAR HOOK, LEFT; OFFSET LAMINAR HOOK, RIGHT; DRILL BIT; DRILL BIT; DRILL BIT; DRILL BIT; ADJ CROSSLINK - SMALL; ADJ CROSSLINK - MEDIUM; ADJ CROSSLINK - LARGE; ROD; ROD; AXIAL DOMINO; OFFSET DOMINO; OFFSET DOMINO; AXIAL DOMINO; CABLE CONNECTOR; MAS CROSSLINK; SMALL MAS CROSSLINK; MEDIUM MAS CROSSLINK; LARGE MAS CROSSLINK; CROSSLINK CONNECTOR CLIP; CONNECTOR LOCKING SCREW; MAS CONNECTOR SET SCREW; OPEN LATERAL OFFSET CONNECTOR; ANGLED OPEN LATERAL OFFSET CONNECTOR; TAPERED ROD - TITANIUM; TAPERED ROD - TITANIUM; TAPERED ROD - TITANIUM; TAPERED ROD - TITANIUM; THREADED ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; PRE-CUT/BENT TITANIUM ROD; TAPERED ROD - CHROMALOY PLUS; TAPERED ROD - CHROMALOY PLUS; TAPERED ROD - CHROMALOY PLUS; TAPERED ROD - CHROMALOY PLUS; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; PRE-CUT/BENT CHROMALOY PLUS ROD; CLOSED LATERAL CONNECTOR; Adjustable OC Plate; OPEN LATERAL OFFSET CONNECTOR; OPEN LATERAL OFFSET CONNECTOR; MAS Extension Connector; DRILL BIT
Model identifier: 6902220; 6955240; 6955245; 6955255; 6955273; 6955274; 6955275; 6955406; 6955408; 6955410; 6955412; 6955506; 6955508; 6955510; 6955512; 6955960; 6955965; 6955973; 6955974; 6955975L; 6955975R; 6955977L; 6955977R; 6956010; 6956011; 6956012; 6956013; 7002525; 7002526; 7002527; 7750015; 7750088; 7750348; 7750444; 7750445; 7750475; 7751110; 7752524; 7752525; 7752526; 7752527; 7752528; 7752529; 7753500; 7753619; 7753619A; 7753704; 7753705; 7753706; 7753707; 7753714; 7753720; 7753725; 7753730; 7753735; 7753740; 7753745; 7753750; 7753755; 7753760; 7753765; 7753770; 7753775; 7753780; 7753785; 7753790; 7753804; 7753805; 7753806; 7753807; 7753820; 7753825; 7753830; 7753835; 7753840; 7753845; 7753850; 7753855; 7753860; 7753865; 7753870; 7753880; 7753890; 7753919; 7755279; 7756064; 7756066; 7756071; 7756131
Registration date: October 06, 2023
Source update date: March 31, 2026

Classification

Risk class: Class C
Published category: Orthopaedics

Published parties

Product owner: Medtronic Sofamor Danek USA, Inc.
Registrant / registration holder: MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)

Official description

The VERTEX® Reconstruction System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical, and/or upper thoracic spine. When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors.

Additional source fields

Product owner address: 1800 Pyramid Place, Memphis, TN 38132, United States
Registrant address: 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.