Cleared Traditional

K851864 - SPINAL STABILIZING UNIT

K851864 · Counterstress Products, Inc. · Orthopedic device
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Dec 1985
Decision
234d
Days
-
Risk

K851864 is an FDA 510(k) clearance for the SPINAL STABILIZING UNIT.

Submitted by Counterstress Products, Inc. (La Mesa, US). The FDA issued a Cleared decision on December 16, 1985 after a review of 234 days - an extended review cycle.

This device falls under the Orthopedic 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K851864

510(k) Number K851864 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1985
Decision Date December 16, 1985
Days to Decision 234 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 122d · This submission: 234d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -
K851864 · SPINAL STABILIZING UNIT
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