Golden Isles Pedicle Screw System

FDA 510(k) K212185 · Intelivation, LLC

Substantially Equivalent

510(k) numberK212185

Submission

Device name
Golden Isles Pedicle Screw System
Applicant
Intelivation, LLC
Saint Simons Island, GA, US
Received
July 13, 2021
Decision date
August 19, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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Questions and answers

When was Golden Isles Pedicle Screw System cleared by the FDA?

Golden Isles Pedicle Screw System (K212185) received a 510(k) decision of Substantially Equivalent on August 19, 2021, 37 days after the submission was received.

What is the product code of K212185?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.