510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K021564Substantially Equivalent

Incompass Spinal Fixation System

Spinal Concepts, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021564 is the FDA 510(k) clearance record for INCOMPASS SPINAL FIXATION SYSTEM, a class II device, cleared for Spinal Concepts, Inc. on under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). FDA records list 46 510(k) clearances for Spinal Concepts, Inc., from to . As of , FDA records show one recall naming K021564.

Clearance record

Decision date
Received
(165 days to decision)
Product code
KWQ Appliance, Fixation, Spinal Intervertebral Body
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Spinal Concepts, Inc. 12012 Technology Blvd., #100, Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWQ

Trailing 12 months
11 clearances under product code KWQ in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code KWQ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20262
March 20263
April 20261
May 20262
June 20260
July 20261
August 20260
September 20261
October 20260