NovoStitch Plus Meniscal Repair System

FDA 510(k) K143356 · Ceterix Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK143356

Submission

Device name
NovoStitch Plus Meniscal Repair System
Applicant
Ceterix Orthopaedics, Inc.
Menlo Park, CA, US
Received
November 24, 2014
Decision date
July 21, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5000
Specialty
General, Plastic Surgery
Implant
Yes

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Questions and answers

When was NovoStitch Plus Meniscal Repair System cleared by the FDA?

NovoStitch Plus Meniscal Repair System (K143356) received a 510(k) decision of Substantially Equivalent on July 21, 2015, 239 days after the submission was received.

What is the product code of K143356?

The FDA product code is GAT – Suture, Nonabsorbable, Synthetic, Polyethylene, a Class II (moderate risk) device regulated under 21 CFR 878.5000.