Cleared Traditional

K780706 - LUMBAR NERVE ROOT SHIELD

K780706 · Heyer Schulte Corp. · Neurology device
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Sep 1978
Decision
135d
Days
-
Risk

K780706 is an FDA 510(k) clearance for the LUMBAR NERVE ROOT SHIELD.

Submitted by Heyer Schulte Corp. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1978 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Heyer Schulte Corp. devices

FDA 510(k) Submission Details - K780706

510(k) Number K780706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1978
Decision Date September 07, 1978
Days to Decision 135 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 149d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -