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Centinel Spine Prodiscยฎ C Vivo Cervical Disc Prosthesis - HSA Registration DE0014465

Access comprehensive regulatory information for Centinel Spine Prodiscยฎ C Vivo Cervical Disc Prosthesis in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0014465 and owned by Centinel Spine, Inc.. The device was registered on December 17, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0014465
Centinel Spine Prodiscยฎ C Vivo Cervical Disc Prosthesis
HSA Registration Number: DE0014465
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Product Description

It is used to replace a cervical intervertebral disc, to restore disc height and maintain segmental motion.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0014465
Registration Date
December 17, 2013
Change Notification Approval Date
August 02, 2019
Retention Due Date
December 16, 2025
Product Owner
Short Name
Centinel Spine, Inc.
Address
900 Airport Road, Suite 3B, West Chester, Pennsylvania 19380, UNITED STATES
Registrant
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-05, SINGAPORE 159349
Importer
Address
5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
Implant-Holder size M+MD Implant-Holder size L+LD Implant-Holder siz XL+XLD Holder f/Trial Implant Positioner Stop f/Implant-Holder Shaft f/Implant-Holder Spacer Clamp sizes M/MD height 5mm Spacer Clamp sizes M/MD height 6mm Spacer Clamp sizes M/MD height 7mm Spacer Clamp sizes L/LD height 5mm Spacer Clamp sizes L/LD height 6mm Spacer Clamp sizes L/LD height 7mm Spacer Clamp sizes XL/XLD height 5mm Spacer Clamp sizes XL/XLD height 6mm Spacer Clamp sizes XL/XLD height 7mm Remover Clamp sizes M/MD Remover Clamp sizes L/LD Remover Clamp sizes XL/XLD Trial-Implant, convex M, 15x12mm, height 5mm Trial-Implant, convex M, 15x12mm, height 6mm Trial-Implant, convex M, 15x12mm, height 7mm Trial-Implant, convex MD, 15x14mm, height 5mm Trial-Implant, convex MD, 15x14mm, height 6mm Trial-Implant, convex MD, 15x14mm, height 7mm Trial-Implant, convex L, 17x14mm, height 5mm Trial-Implant, convex L, 17x14mm, height 6mm Trial-Implant, convex L, 17x14mm, height 7mm Trial-Implant, convex LD, 17x16mm, height 5mm Trial-Implant, convex LD, 17x16mm, height 6mm Trial-Implant, convex LD, 17x16mm, height 7mm Trial-Implant, convex XL, 19x16mm, height 5mm Trial-Implant, convex XL, 19x16mm, height 6mm Trial-Implant, convex XL, 19x16mm, height 7mm Trial-Implant, convex XLD, 19x18mm, height 5mm Trial-Implant, convex XLD, 19x18mm, height 6mm Trial-Implant, convex XLD, 19x18mm, height 7mm Slide Hammer f/Cervic-Spine Prodisc-C Vivo, convex, size M, 15x12mm, H5mm Prodisc-C Vivo, convex, size M, 15x12mm, H6mm Prodisc-C Vivo, convex, size M, 15x12mm, H7mm Prodisc-C Vivo, convex, size MD, 15x14mm, H5mm Prodisc-C Vivo, convex, size MD, 15x14mm, H6mm Prodisc-C Vivo, convex, size MD, 15x14mm, H7mm Prodisc-C Vivo, convex, size L, 17x14mm, H5mm Prodisc-C Vivo, convex, size L, 17x14mm, H6mm Prodisc-C Vivo, convex, size L, 17x14mm, H7mm Prodisc-C Vivo, convex, size LD, 17x16mm, H5mm Prodisc-C Vivo, convex, size LD, 17x16mm, H6mm Prodisc-C Vivo, convex, size LD, 17x16mm, H7mm Prodisc-C Vivo, convex, size XL, 19x16mm, H5mm Prodisc-C Vivo, convex, size XL, 19x16mm, H6mm Prodisc-C Vivo, convex, size XL, 19x16mm, H7mm Prodisc-C Vivo, convex, size XLD, 19x18mm, H5mm Prodisc-C Vivo, convex, size XLD, 19x18mm, H6mm Prodisc-C Vivo, convex, size XLD, 19x18mm, H7mm
Model Identifier(s)
03.670.201 03.670.202 03.670.203 03.670.204 03.670.207 03.670.212 03.670.213 03.670.305 03.670.306 03.670.307 03.670.315 03.670.316 03.670.317 03.670.325 03.670.326 03.670.327 03.670.400 03.670.410 03.670.420 03.670.925 03.670.926 03.670.927 03.670.935 03.670.936 03.670.937 03.670.945 03.670.946 03.670.947 03.670.955 03.670.956 03.670.957 03.670.965 03.670.966 03.670.967 03.670.975 03.670.976 03.670.977 03.820.282 04.670.925S 04.670.926S 04.670.927S 04.670.935S 04.670.936S 04.670.937S 04.670.945S 04.670.946S 04.670.947S 04.670.955S 04.670.956S 04.670.957S 04.670.965S 04.670.966S 04.670.967S 04.670.975S 04.670.976S 04.670.977S