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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 the device name listed in this FDA 510(k) record. The listed applicant is Ceterix Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-08-01 under 510(k) 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. The listed applicant is Ceterix Orthopaedics, Inc.. The 510(k) number is K181772.

When did NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) receive FDA 510(k) clearance?

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

Who is the listed applicant for NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)?

The FDA 510(k) record lists Ceterix Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Ceterix Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180531NovoStitch Pro Meniscal Repair System

Related Devices (Code: GAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

Official Source

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

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