Cleared Traditional

K851864 - SPINAL STABILIZING UNIT (FDA 510(k) Clearance)

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.

View all Counterstress Products, Inc. devices

Submission Details

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

Product Code -
Device Class -