Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Flex-ThreadTM Distal Fibula Intramedullary Nail System

K-Number: K202858 · 2021-01-22

ApplicantConventus Orthopaedics, LLC
Decision Date2021-01-22
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flex-ThreadTM Distal Fibula Intramedullary Nail System is a medical device manufactured by Conventus Orthopaedics, LLC. It received FDA 510(k) clearance on 2021-01-22 under approval number K202858. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flex-ThreadTM Distal Fibula Intramedullary Nail System?

Flex-ThreadTM Distal Fibula Intramedullary Nail System is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Conventus Orthopaedics, LLC. The 510(k) number is K202858.

When was Flex-ThreadTM Distal Fibula Intramedullary Nail System approved by the FDA?

Flex-ThreadTM Distal Fibula Intramedullary Nail System received FDA 510(k) clearance on 2021-01-22, under approval number K202858.

What company makes Flex-ThreadTM Distal Fibula Intramedullary Nail System?

Flex-ThreadTM Distal Fibula Intramedullary Nail System is manufactured by Conventus Orthopaedics, LLC.

What is the FDA product code for Flex-ThreadTM Distal Fibula Intramedullary Nail System?

The FDA product code for Flex-ThreadTM Distal Fibula Intramedullary Nail System is HSB.

Related Clinical Trials

NCT07211035 Effect of the Amplifi™ Vein Dilation System on Outflow Vein Dilation and AV Fistula Maturation (AMPLIFI-1) RECRUITING NCT07431723 Creation of Compression Anastomosis Using the GT Metabolic Magnet System RECRUITING NCT06977035 Nerve Conduction Study for Assessment of Peripheral Neuropathy in Rheumatoid Arthritis Patients on the Janus Kinase Inhibitor Baricitinib RECRUITING NCT07569575 Magnesium-Titanium Hybrid Intramedullary Nail System For Long Bone Fractures NOT_YET_RECRUITING NCT07546279 The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects. RECRUITING NCT07538141 The Hyalex MTP Study RECRUITING

Related Devices (Code: HSB)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

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.

↑