Cleared Traditional

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

K946258 · Spinalight, Inc. · Physical Medicine device
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Nov 1995
Decision
349d
Days
-
Risk

K946258 is an FDA 510(k) clearance for the MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Spinalight, Inc. (Woodstock, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Spinalight, Inc. devices

Submission Details

510(k) Number K946258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1994
Decision Date November 20, 1995
Days to Decision 349 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 115d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -