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

FDA 510(k) K181772 · Ceterix Orthopaedics, Inc.

Substantially Equivalent

510(k) numberK181772

Submission

Device name
NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
Applicant
Ceterix Orthopaedics, Inc.
Fremont, CA, US
Received
July 3, 2018
Decision date
August 1, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 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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More from Threadstone, LLC

510(k)DeviceDecision
K180531NovoStitch Pro Meniscal Repair SystemGAT · Special 03/29/2018SE
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Questions and answers

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

NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) (K181772) received a 510(k) decision of Substantially Equivalent on August 1, 2018, 29 days after the submission was received.

What is the product code of K181772?

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