Cleared Traditional

K132122 - KESTREL POSTERIOR CERVICAL SPINE SYSTEM

K132122 is an FDA 510(k) clearance for KESTREL POSTERIOR CERVICAL SPINE SYSTEM, manufactured by Omni Surgical, LLC Dba Spine360. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K132122 · Omni Surgical, LLC Dba Spine360 · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
196d
Days
Class 2
Risk

K132122 is an FDA 510(k) clearance for the KESTREL POSTERIOR CERVICAL SPINE SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Omni Surgical, LLC Dba Spine360 (Austin, US). The FDA issued a Cleared decision on January 22, 2014 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Omni Surgical, LLC Dba Spine360 devices

FDA 510(k) Submission Details - K132122

510(k) Number K132122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2013
Decision Date January 22, 2014
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWP Appliance, Fixation, Spinal Interlaminal

All 337
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K132122.
VIRAGE OCT SPINAL FIXATION SYSTEM
K133556 · Zimmer Spine, Inc. · Jun 2014
BLACKBIRD SPINAL SYSTEM
K133214 · Choicespine, LP · Mar 2014
CENTURION POCT SYSTEM
K131833 · Orthofix, Inc. · Jan 2014
SYNAPSE SYSTEM
K133698 · Synthes USA Products, LLC · Jan 2014
CERTEX OCT SPINAL IMPLANT SYSTEM
K133094 · X-Spine Systems, Inc. · Dec 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · Corelink, LLC · Nov 2013