Cleared Traditional

K946258 - MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT

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.

FDA 510(k) Submission Details - K946258

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 116d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

LXM Device Classification - Class 0,

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

Regulatory Peers - LXM Manipulator, Plunger-like Joint

All 30
Devices cleared under the same product code (LXM) and FDA review panel - the closest regulatory comparables to K946258.
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K946258 · MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
Download PDF Spinalight, Inc.