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)

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)

K-Number: K181772 · 2018-08-01

ApplicantCeterix Orthopaedics, Inc.
Decision Date2018-08-01
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) is a medical device manufactured by Ceterix Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-08-01 under approval number K181772. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)?

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) is a medical device that received FDA 510(k) clearance on 2018-08-01. It is manufactured by Ceterix Orthopaedics, Inc.. The 510(k) number is K181772.

When was NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) approved by the FDA?

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) received FDA 510(k) clearance on 2018-08-01, under approval number K181772.

What company makes NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)?

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) is manufactured by Ceterix Orthopaedics, Inc..

What is the FDA product code for NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)?

The FDA product code for NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) is GAT.

Related Clinical Trials

NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT03298477 EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study COMPLETED NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT03382457 Clinical Study of Edwards Cardioband FIT Valve Repair System ACTIVE_NOT_RECRUITING

Other Devices by Ceterix Orthopaedics, Inc.

K180531NovoStitch Pro Meniscal Repair System

Related Devices (Code: GAT)

K160854MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation SutureBiomet Manafacturing Corp. K162247PERMATAPEMedos International SARL K162310XBraid TT Suture TapeStryker K161638SPEEDTRAP Graft Preparation SystemMedos International SARL K153089'cottony' II TAPE, PLEDGETSTeleflexmedical, Inc. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse CurvedIvy Sports Medicine, LLC

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.

↑