HSA · registration DE0509972Medtronic Sofamor Danek ANTERALIGN™ SPINAL SYSTEM WITH TITAN nanoLOCK™ SURFACE TECHNOLOGY
- Registration number
- DE0509972
- Model name
- SPACER 46500610 SM TI 6DG 32X25X10MM; SPACER 46500612 SM TI 6DG 32X25X12MM; SPACER 46500614 SM TI 6DG 32X25X14MM; SPACER 46500616 SM TI 6DG 32X25X16MM; SPACER 46501210 SM TI 12DG 32X25X10MM; SPACER 46501212 SM TI 12DG 32X25X12MM; SPACER 46501214 SM TI 12DG 32X25X14MM; SPACER 46501216 SM TI 12DG 32X25X16MM; SPACER 46501218 SM TI 12DG 32X25X18MM; SPACER 46501812 SM TI 18DG 32X25X12MM; SPACER 46501814 SM TI 18DG 32X25X14MM; SPACER 46501816 SM TI 18DG 32X25X16MM; SPACER 46501818 SM TI 18DG 32X25X18MM; SPACER 46502416 SM TI 24DG 32X25X16MM; SPACER 46502418 SM TI 24DG 32X25X18MM; SPACER 46510610 MD TI 6DG 37X29X10MM; SPACER 46510612 MD TI 6DG 37X29X12MM; SPACER 46510614 MD TI 6DG 37X29X14MM; SPACER 46510616 MD TI 6DG 37X29X16MM; SPACER 46511210 MD TI 12DG 37X29X10MM; SPACER 46511212 MD TI 12DG 37X29X12MM; SPACER 46511214 MD TI 12DG 37X29X14MM; SPACER 46511216 MD TI 12DG 37X29X16MM; SPACER 46511218 MD TI 12DG 37X29X18MM; SPACER 46511220 MD TI 12DG 37X29X20MM; SPACER 46511814 MD TI 18DG 37X29X14MM; SPACER 46511816 MD TI 18DG 37X29X16MM; SPACER 46511818 MD TI 18DG 37X29X18MM; SPACER 46512418 MD TI 24DG 37X29X18MM; SPACER 46513020 MD TI 30DG 37X29X20MM; SPACER 46520610 LG TI 6DG 42X32X10MM; SPACER 46520612 LG TI 6DG 42X32X12MM; SPACER 46520614 LG TI 6DG 42X32X14MM; SPACER 46520616 LG TI 6DG 42X32X16MM; SPACER 46521212 LG TI 12DG 42X32X12MM; SPACER 46521214 LG TI 12DG 42X32X14MM; SPACER 46521216 LG TI 12DG 42X32X16MM; SPACER 46521218 LG TI 12DG 42X32X18MM; SPACER 46521816 LG TI 18DG 42X32X16MM; SPACER 46521818 LG TI 18DG 42X32X18MM; SPACER 46522418 LG TI 24DG 42X32X18MM; TRIAL 46820210 SM 12DG 32X25X10MM; TRIAL 46820212 SM 12DG 32X25X12MM; TRIAL 46820214 SM 12DG 32X25X14MM; TRIAL 46820216 SM 12DG 32X25X16MM; TRIAL 46820218 SM 12DG 32X25X18MM; TRIAL 46820608 SM 6DG 32X25X8MM; TRIAL 46820610 SM 6DG 32X25X10MM; TRIAL 46820612 SM 6DG 32X25X12MM; TRIAL 46820614 SM 6DG 32X25X14MM; TRIAL 46821210 MD 12DG 37X29X10MM; TRIAL 46821212 MD 12DG 37X29X12MM; TRIAL 46821214 MD 12DG 37X29X14MM; TRIAL 46821216 MD 12DG 37X29X16MM; TRIAL 46821218 MD 12DG 37X29X18MM; TRIAL 46821320 MD 30DG 37X29X20MM; TRIAL 46821418 MD 24DG 37X29X18MM; TRIAL 46821610 MD 6DG 37X29X10MM; TRIAL 46821612 MD 6DG 37X29X12MM; TRIAL 46821614 MD 6DG 37X29X14MM; TRIAL 46821616 MD 6DG 37X29X16MM; TRIAL 46821618 MD 6DG 37X29X18MM; TRIAL 46821814 MD 18DG 37X29X14MM; TRIAL 46821816 MD 18DG 37X29X16MM; TRIAL 46821818 MD 18DG 37X29X18MM; TRIAL 46822212 LG 12DG 42X32X12MM; TRIAL 46822214 LG 12DG 42X32X14MM; TRIAL 46822216 LG 12DG 42X32X16MM; TRIAL 46822218 LG 12DG 42X32X18MM; TRIAL 46822610 LG 6DG 42X32X10MM; TRIAL 46822612 LG 6DG 42X32X12MM; TRIAL 46822614 LG 6DG 42X32X14MM
- Model identifier
- 46500610; 46500612; 46500614; 46500616; 46501210; 46501212; 46501214; 46501216; 46501218; 46501812; 46501814; 46501816; 46501818; 46502416; 46502418; 46510610; 46510612; 46510614; 46510616; 46511210; 46511212; 46511214; 46511216; 46511218; 46511220; 46511814; 46511816; 46511818; 46512418; 46513020; 46520610; 46520612; 46520614; 46520616; 46521212; 46521214; 46521216; 46521218; 46521816; 46521818; 46522418; 46820210; 46820212; 46820214; 46820216; 46820218; 46820608; 46820610; 46820612; 46820614; 46821210; 46821212; 46821214; 46821216; 46821218; 46821320; 46821418; 46821610; 46821612; 46821614; 46821616; 46821618; 46821814; 46821816; 46821818; 46822212; 46822214; 46822216; 46822218; 46822610; 46822612; 46822614
- Registration date
- October 24, 2024
- Risk class
- Class C
- Product owner
- Medtronic Sofamor Danek USA, Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Intended to be used in spinal fusion procedures on skeletally mature patients with symptomatic Degenerative Disc Disease, degenerative spondylolisthesis, and/or spinal stenosis, at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion. These patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. These patients should have had six months of nonoperative treatment prior to treatment with this device. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a combination thereof. The Anteralign™ LS interbody cage may be used as a stand-alone device or in conjunction with supplemental fixation.
- Product owner address
- 1800 Pyramid Place, Memphis, TN 38132, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
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.