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K2M Terra Nova Minimally Invasive Access System - HSA Registration DE0508257

Access comprehensive regulatory information for K2M Terra Nova 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 DE0508257 and owned by K2M, Inc.. The device was registered on June 30, 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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CLASS B
DE0508257
K2M Terra Nova Minimally Invasive Access System
HSA Registration Number: DE0508257
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Product Description

A surgical instrument for separating tissue or other anatomical parts to expose or access organs or tissues to permit examination or intervention.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0508257
Registration Date
June 30, 2023
Retention Due Date
June 29, 2025
Product Owner
Short Name
K2M, Inc.
Address
600 Hope Parkway SE, Leesburg, Virginia, 20175, 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)
Angled Blade; Size 23 x 40 mm Angled Blade; Size 23 x 50 mm Angled Blade; Size 23 x 60 mm Angled Blade; Size 23 x 70 mm Angled Blade; Size 23 x 80 mm Angled Blade; Size 23 x 90 mm Straight Blade; Size 23 x 40 mm Straight Blade; Size 23 x 50 mm Straight Blade; Size 23 x 60 mm Straight Blade; Size 23 x 70 mm Straight Blade; Size 23 x 80 mm Straight Blade; Size 23 x 90 mm Small Retractor Distractor; Size 50 mm Small Retractor Distractor; Size 70 mm Small Retractor Distractor; Size 90 mm Large Retractor Distractor; Size 50 mm Large Retractor Distractor; Size 70 mm Large Retractor Distractor; Size 90 mm Medium Retractor Distractor; Size 70 mm Guide Wire; Size Ø1.4 x 230 mm
Model Identifier(s)
1501-90005 1501-90006 1501-90007 1501-90008 1501-90009 1501-90010 1501-90015 1501-90016 1501-90017 1501-90018 1501-90019 1501-90020 1501-90035 1501-90037 1501-90039 1501-90041 1501-90043 1501-90045 1501-90055 1501-90060