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Singapore HSA registration DE0506492

ConMed TruShot™ with Y-Knot® All-Suture Anchor with Needles

Singapore flagSingapore·CLASS C·CONMED CORPORATION·Registered December 17, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration information
Registration Number
DE0506492
Registration Date
December 17, 2021
Change Notification Approval Date
November 21, 2023
Retention Due Date
December 16, 2025
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.
Product Owner
Name
CONMED CORPORATION
Short Name
CONMED CORPORATION
Address
525 FRENCH ROAD, UTICA, NEW YORK 13502, UNITED STATES OF AMERICA, UNITED STATES
Registrant
Name
CONMED SINGAPORE PTE. LTD.
Address
10 JALAN KILANG, BT Merah Enterprise Centre, #03-01, SINGAPORE 159410
Importer
Name
CONMED SINGAPORE PTE. LTD.
Address
10 JALAN KILANG, BT MERAH ENTERPRISE CENTRE, #03-01, SINGAPORE 159410
Model information
Model Name(s)
TruShot™ with Y-Knot® 1.3mm All-Suture Anchor with one #2 (5 metric) Hi-Fi® Suture with Needles TruShot™ with Y-Knot® 1.8mm All-Suture Anchor with two #2 (5 metric) Hi-Fi® Suture with Needles
Model Identifier(s)
Y13TN Y18TN
About this record

Access comprehensive regulatory information for ConMed TruShot™ with Y-Knot® 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 DE0506492 and owned by CONMED CORPORATION. The device was registered on December 17, 2021.

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 C