Orthopedic Alliance Spine System

FDA 510(k) K033826 · Orthopedic Alliance, LLC

Substantially Equivalent

510(k) numberK033826

Submission

Device name
Orthopedic Alliance Spine System
Applicant
Orthopedic Alliance, LLC
Murrieta, CA, US
Received
December 10, 2003
Decision date
July 1, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MNI – Orthosis, Spinal Pedicle 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 Orthopedic Alliance Spine System cleared by the FDA?

Orthopedic Alliance Spine System (K033826) received a 510(k) decision of Substantially Equivalent on July 1, 2004, 204 days after the submission was received.

What is the product code of K033826?

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