CurvaFix Intramedullary Rodscrew System

FDA 510(k) K180050 · Curvafix, Inc.

Substantially Equivalent

510(k) numberK180050

Submission

Device name
CurvaFix Intramedullary Rodscrew System
Applicant
Curvafix, Inc.
Bellevue, WA, US
Received
January 8, 2018
Decision date
March 1, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HWC – Screw, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was CurvaFix Intramedullary Rodscrew System cleared by the FDA?

CurvaFix Intramedullary Rodscrew System (K180050) received a 510(k) decision of Substantially Equivalent on March 1, 2019, 417 days after the submission was received.

What is the product code of K180050?

The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.