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FDA 510(k)

Betta Link Knotless Implant System

K-Number: K210498 · 2021-03-24

ApplicantT.A.G. Medical Products Corporation, Ltd.
Decision Date2021-03-24
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Betta Link Knotless Implant System is a medical device manufactured by T.A.G. Medical Products Corporation, Ltd.. It received FDA 510(k) clearance on 2021-03-24 under approval number K210498. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Betta Link Knotless Implant System?

Betta Link Knotless Implant System is a medical device that received FDA 510(k) clearance on 2021-03-24. It is manufactured by T.A.G. Medical Products Corporation, Ltd.. The 510(k) number is K210498.

When was Betta Link Knotless Implant System approved by the FDA?

Betta Link Knotless Implant System received FDA 510(k) clearance on 2021-03-24, under approval number K210498.

What company makes Betta Link Knotless Implant System?

Betta Link Knotless Implant System is manufactured by T.A.G. Medical Products Corporation, Ltd..

What is the FDA product code for Betta Link Knotless Implant System?

The FDA product code for Betta Link Knotless Implant System is MBI.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by T.A.G. Medical Products Corporation, Ltd.

K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K202178VersaLoop Anchor System K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K231400Bladeless Trocar – Artemis Lap Cannula K230058Bladeless Trocar – Artemis Lap Cannula

Related Devices (Code: MBI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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