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Spinal Touch

by Fasstech

510(k) K961212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Overview

The SPINAL TOUCH medical device is a high-precision goniometer used in orthopedic procedures to measure joint angles and monitor treatment outcomes. It features advanced motor control, accuracy, and reliability, making it an essential tool for healthcare professionals.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK961212 Date12 Jun 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KQX
Device Class
Class I
Regulation
21 CFR Part 888.1500
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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