MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT— 510(k) K946258

Name: FDA 510(k) clearance K946258
Creator: U.S. Food and Drug Administration
Published: 1995-11-20

Substantially Equivalent

Spinalight, Inc.

FDA 510(k) clearance K946258 for MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT, Substantially Equivalent on 1995-11-20. Applicant: Spinalight, Inc.. Device class: Unclassified.

Clearance details

Applicant: Spinalight, Inc.
Product code: Code LXM
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-12-06
Decision date: 1995-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodstock, GA, US

Download summary PDF View on FDA.gov ↗

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K933621 — HILO TABLE1994-01-07
K933622 — FLEXION DISTRACTION TABLE1994-01-07

Recalls naming K946258

K-number listed on FDA's recall record

Z-1809-2013 — Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.Class II·Terminated·Advanced Orthogonal Equipment, Incorporated·20130306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K946258.

Data sourced from openFDA. This site is unofficial and independent of the FDA.