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)

Syntec Femoral Nail Extended System

K-Number: K202935 · 2020-10-28

ApplicantSyntec Scientific Corporation
Decision Date2020-10-28
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syntec Femoral Nail Extended System is a medical device manufactured by Syntec Scientific Corporation. It received FDA 510(k) clearance on 2020-10-28 under approval number K202935. 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 Syntec Femoral Nail Extended System?

Syntec Femoral Nail Extended System is a medical device that received FDA 510(k) clearance on 2020-10-28. It is manufactured by Syntec Scientific Corporation. The 510(k) number is K202935.

When was Syntec Femoral Nail Extended System approved by the FDA?

Syntec Femoral Nail Extended System received FDA 510(k) clearance on 2020-10-28, under approval number K202935.

What company makes Syntec Femoral Nail Extended System?

Syntec Femoral Nail Extended System is manufactured by Syntec Scientific Corporation.

What is the FDA product code for Syntec Femoral Nail Extended System?

The FDA product code for Syntec Femoral Nail Extended System is HSB.

Related Clinical Trials

NCT06885931 Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications) RECRUITING NCT05454891 Extended Bolus for Meals in a Closed-loop System COMPLETED NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07102160 Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking RECRUITING NCT06732050 Influence of Intraoperative Nociception Guided Analgesia on Perioperative Total Analgesic Requirement Endometriosis COMPLETED NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING

Other Devices by Syntec Scientific Corporation

K161327SYNTEC HUMERAL NAIL SYSTEM K191617Syntec Tibial Nail System K181296Syntec Femoral Nail System K200933Syntec Non-Sterile Steinmann Pins System K202790Syntec Orthodontic Mini Screw Extended System

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.

↑