510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132122Substantially Equivalent

Kestrel Posterior Cervical Spine System

Omni Surgical, LLC dba Spine360, Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132122 is the FDA 510(k) clearance record for KESTREL POSTERIOR CERVICAL SPINE SYSTEM, a class II device, cleared for Omni Surgical, LLC Dba Spine360 on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list one 510(k) clearance for Omni Surgical, LLC Dba Spine360. As of , FDA records show no recalls naming K132122.

Clearance record

Decision date
Received
(196 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Omni Surgical, LLC Dba Spine360 5000 Plz. On The Lake, Suite 305, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260