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
K983353Substantially Equivalent

Scs Spinal System

Orthotec, Inc., Pleasant Hill CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983353 is the FDA 510(k) clearance record for SCS SPINAL SYSTEM, a class II device, cleared for Orthotec, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list one 510(k) clearance for Orthotec, Inc. As of , FDA records show no recalls naming K983353.

Clearance record

Decision date
Received
(86 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Orthotec, Inc. 200 Gregory Ln. Suite C-100, Pleasant Hill CA
510(k) summary
Summary
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