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ConMed TruShot™ with Y-Knot® Shallow All-Suture Anchor with Needles - HSA Registration DE0506707

Access comprehensive regulatory information for ConMed TruShot™ with Y-Knot® Shallow All-Suture Anchor with Needles in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0506707 and owned by CONMED CORPORATION. The device was registered on March 09, 2022.

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
DE0506707
ConMed TruShot™ with Y-Knot® Shallow All-Suture Anchor with Needles
HSA Registration Number: DE0506707
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Product Description

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period. The non-absorbable suture anchors are indicated to reattach soft tissue to bone in the following orthopedic surgical procedures: Ankle Stabilisation Achilles, Collateral Ligament Repairs, Extensor Tendon Repairs, Scapholunate Repairs, Epicondyle Repairs, Biceps Repair.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506707
Registration Date
March 09, 2022
Change Notification Approval Date
November 21, 2023
Retention Due Date
March 08, 2026
Product Owner
Short Name
CONMED CORPORATION
Address
525 FRENCH ROAD, UTICA, NEW YORK 13502, UNITED STATES OF AMERICA, UNITED STATES
Registrant
Address
10 JALAN KILANG, BT Merah Enterprise Centre, #03-01, SINGAPORE 159410
Importer
Address
10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410
Model Information
Model Name(s)
TruShot™ with Y-Knot® Shallow All-Suture Anchor (1.7mm) with one #0 (3.5 metric) Hi-Fi® Suture with Needles TruShot™ with Y-Knot® Shallow All-Suture Anchor (1.7mm) with one #2-0 (3 metric) Hi-Fi® Suture with Needles
Model Identifier(s)
YSTN0 YSTN20