510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K021979Substantially Equivalent

Smisson Stabilization System

Smisson-Cartledge, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K021979 is the FDA 510(k) clearance record for SMISSON STABILIZATION SYSTEM, a class II device, cleared for Smisson-Cartledge on under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body). FDA records list one 510(k) clearance for Smisson-Cartledge. As of , FDA records show no recalls naming K021979.

Clearance record

Decision date
Received
(375 days to decision)
Product code
KWQ Appliance, Fixation, Spinal Intervertebral Body
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Smisson-Cartledge 3722 Ave. Sausalito, Irvine CA
510(k) summary
Statement
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