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Singapore HSA registration DE0507970

Stryker Canyon® TL Minimally Invasive Access System

Singapore flagSingapore·CLASS B·K2M, Inc.·Registered April 04, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0507970
Registration Date
April 04, 2023
Change Notification Approval Date
May 17, 2023
Retention Due Date
April 03, 2026
Product description
It is a screw-based retractor design allows for stability and limits retractor movement, top-loading frame with independent arms to facilitate easy, rigid blade attachment. The retractor frame provides toeing, +25º and -5º, to increase disc space access and visualization, low-profile lateral blades with 15º bend allowing for increased access. Canyon TL is compatible with the Everest MI and Everest MI XT spinal fixation systems.
Product Owner
Name
K2M, Inc.
Short Name
K2M, Inc.
Address
600 Hope Parkway SE, Leesburg, Virginia, 20175, UNITED STATES
Registrant
Name
STRYKER SINGAPORE PRIVATE LIMITED
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Name
STRYKER SINGAPORE PRIVATE LIMITED
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model information
Model Name(s)
Angled Retractor Distractor, Narrow 40 mm Angled Retractor Distractor, Narrow 50 mm Angled Retractor Distractor, Narrow 60 mm Angled Retractor Distractor, Narrow 70 mm Angled Retractor Distractor, Narrow 80 mm Angled Retractor Distractor, Narrow 90 mm Angled Retractor Distractor, Standard 40 mm Angled Retractor Distractor, Standard 50 mm Angled Retractor Distractor, Standard 60 mm Angled Retractor Distractor, Standard 70 mm Angled Retractor Distractor, Standard 80mm Angled Retractor Distractor, Standard 90 mm Straight Blade, 23 x 40 mm Straight Blade, 23 x 50 mm Straight Blade, 23 x 60 mm Straight Blade, 23 x 70 mm Straight Blade, 23 x 80 mm Straight Blade, 23 x 90 mm Straight Blade, 14 x 40 mm Straight Blade, 14 x 50 mm Straight Blade, 14 x 60 mm Straight Blade, 14 x 70 mm Straight Blade, 14 x 80 mm Straight Blade, 14 x 90 mm Angled Swivel Retractor Distractor, Standard 50 mm Angled Swivel Retractor Distractor, Standard 70 mm Angled Swivel Retractor Distractor, Standard 90 mm
Model Identifier(s)
6401-90132 6401-90133 6401-90134 6401-90135 6401-90136 6401-90137 6401-90142 6401-90143 6401-90144 6401-90145 6401-90146 6401-90147 6401-90173 6401-90174 6401-90175 6401-90176 6401-90177 6401-90178 6401-90183 6401-90184 6401-90185 6401-90186 6401-90187 6401-90188 6401-90204 6401-90206 6401-90208
About this record

Access comprehensive regulatory information for Stryker Canyon® TL Minimally Invasive Access System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507970 and owned by K2M, Inc.. The device was registered on April 04, 2023.

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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