Kestrel Posterior Cervical Spine System

FDA 510(k) K132122 · Omni Surgical, LLC Dba Spine360

Substantially Equivalent

510(k) numberK132122

Submission

Device name
Kestrel Posterior Cervical Spine System
Applicant
Omni Surgical, LLC Dba Spine360
Austin, TX, US
Received
July 10, 2013
Decision date
January 22, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWP – Appliance, Fixation, Spinal Interlaminal
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3050
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWP

510(k)DeviceApplicantDecision
K143278LnK Posterior Cervical Fixation SystemKWP · Traditional L&K BIOMED Co., Ltd.07/29/2015SE
K150753OASYS SystemKWP · Traditional Stryker Corporation06/09/2015SE
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemKWP · Special Precision Spine, Inc.06/04/2015SE
K142867Reliance Posterior Cervical-Thoracic SystemKWP · Special Reliance Medical Systems, LLC04/29/2015SE
K150254Streamline OCT Occipito-Cervico-Thoracic SystemKWP · Traditional Pioneer Surgical Technology, Inc. (Dba Rti…04/28/2015SE
K142253SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/23/2015SE
K150229SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K143249SOLSTICE OCT SystemKWP · Traditional Life Spine, Inc.04/07/2015SE
K142741OASYS SystemKWP · Traditional Stryker Corporation01/15/2015SE
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemKWP · Special K2m12/22/2014SE

Questions and answers

When was Kestrel Posterior Cervical Spine System cleared by the FDA?

Kestrel Posterior Cervical Spine System (K132122) received a 510(k) decision of Substantially Equivalent on January 22, 2014, 196 days after the submission was received.

What is the product code of K132122?

The FDA product code is KWP – Appliance, Fixation, Spinal Interlaminal, a Class II (moderate risk) device regulated under 21 CFR 888.3050.