510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961212Substantially Equivalent

Spinal Touch

Fasstech, Burlington MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961212 is the FDA 510(k) clearance record for SPINAL TOUCH, a class I device, cleared for Fasstech on under FDA product code KQX (Goniometer, Ac-Powered). FDA records list 9 510(k) clearances for Fasstech, from to . As of , FDA records show no recalls naming K961212.

Clearance record

Decision date
Received
(76 days to decision)
Product code
KQX Goniometer, Ac-Powered
Regulation
21 CFR 888.1500
Device class
Class I
Review panel
Orthopedic
Applicant
Fasstech 155 Middlesex Tpke., Burlington MA
510(k) summary
Statement
Third party review
No

Clearances, product code KQX

Trailing 12 months

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

FDA records show no clearances under product code KQX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KQX, 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