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Stryker Spine Vitoss Bioactive Bone Graft Substitutes - HSA Registration DE0014573

Access comprehensive regulatory information for Stryker Spine Vitoss Bioactive Bone Graft Substitutes in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0014573 and owned by Stryker Spine. The device was registered on December 31, 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 D
DE0014573
Stryker Spine Vitoss Bioactive Bone Graft Substitutes
HSA Registration Number: DE0014573
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Product Description

Vitoss Bioactive Foam Bone Graft Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Bioactive Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Bioactive Foam Bone Graft Substitute is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine, which includes posterolateral fusion procedures) and may be combined with saline, autogenous blood, and/or bone marrow. Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0014573
Registration Date
December 31, 2013
Change Notification Approval Date
August 30, 2022
Retention Due Date
December 30, 2025
Product Owner
Short Name
Stryker Spine
Address
2 Pearl Court, Allendale, NJ 07401-1677, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
Vitoss BA Bioactive Foam Strip, 25X100X4mm Vitoss BA Bioactive Foam Strip, 25X50X4mm Vitoss BA Bioactive Foam Strip, 25X50X8mm Vitoss BA Bioactive Foam Strip, 25X100X8mm Vitoss BA Bioactive Foam Pack, 1.2cc Vitoss BA Bioactive Foam Pack, 2.5cc Vitoss BA Bioactive Foam Pack, 5cc Vitoss BA Bioactive Foam Pack, 10cc Vitoss BA2X Bioactive Bone Graft Substitute, 1.2cc Vitoss BA2X Bioactive Bone Graft Substitute, 2.5cc Vitoss BA2X Bioactive Bone Graft Substitute, 5.0cc Vitoss BA2X Bioactive Bone Graft Substitute, 10cc
Model Identifier(s)
2102-1500 2102-1505 2102-1510 2102-1520 2102-1601 2102-1602 2102-1605 2102-1610 2102-2101 2102-2102 2102-2105 2102-2110