Lowtop Pedicle Screw System

FDA 510(k) K070933 · Sanacor

Substantially Equivalent

510(k) numberK070933

Submission

Device name
Lowtop Pedicle Screw System
Applicant
Sanacor
American Fork, UT, US
Received
April 3, 2007
Decision date
June 13, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNH – Orthosis, Spondylolisthesis Spinal Fixation
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Lowtop Pedicle Screw System cleared by the FDA?

Lowtop Pedicle Screw System (K070933) received a 510(k) decision of Substantially Equivalent on June 13, 2007, 71 days after the submission was received.

What is the product code of K070933?

The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.