Cleared Traditional

K001476 - TORQUE INSTRUMENT, MODEL 8500 (FDA 510(k) Clearance)

K001476 · Spinalight, Inc. · Physical Medicine device
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Aug 2000
Decision
85d
Days
-
Risk

K001476 is an FDA 510(k) clearance for the TORQUE INSTRUMENT, MODEL 8500. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Spinalight, Inc. (Kennesaw, US). The FDA issued a Cleared decision on August 4, 2000 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spinalight, Inc. devices

Submission Details

510(k) Number K001476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2000
Decision Date August 04, 2000
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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