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Singapore HSA registration DE0508206

K2M K2M Lordotic Modular Trials

Singapore flagSingapore·CLASS B·K2M, Inc.·Registered June 16, 2023
Device classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0508206
Registration Date
June 16, 2023
Change Notification Approval Date
September 19, 2023
Retention Due Date
June 15, 2025
Product description
Surgical instruments supplied by Stryker Spine are medical tools designed solely for use in the fitting of spinal implants for patients undergoing spinal surgery. Stryker Spine instruments are intended to be used by trained physicians and hospital staff according to the methods described in the surgical technique, as applicable. Trials are available to aid with interbody size selection. Principles of Operation: Used as a guide during angled trialing to help determine the appropriate interbody implant size.
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)
Lordotic Modular Trial 22x60x08MM 8° Lordotic Modular Trial 22x60x10MM 8° Lordotic Modular Trial 22x60x12MM 8° Lordotic Modular Trial 22x60x14MM 8° Lordotic Modular Trial 22x60x10MM 12° Lordotic Modular Trial 22x60x12MM 12° Lordotic Modular Trial 22x60x14MM 12° Lordotic Modular Trial 22x60x16MM 12°
Model Identifier(s)
AG01-96064 AG01-96065 AG01-96066 AG01-96067 AG01-96086 AG01-96087 AG01-96088 AG01-96089
About this record

Access comprehensive regulatory information for K2M K2M Lordotic Modular Trials in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508206 and owned by K2M, Inc.. The device was registered on June 16, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B