Cleared Traditional

K843013 - H-H TENDEON IMPLANT (FDA 510(k) Clearance)

K843013 · Holter-Hausner Intl. · Orthopedic device
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Apr 1985
Decision
260d
Days
-
Risk

K843013 is an FDA 510(k) clearance for the H-H TENDEON IMPLANT.

Submitted by Holter-Hausner Intl. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1985 after a review of 260 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 Holter-Hausner Intl. devices

Submission Details

510(k) Number K843013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date April 17, 1985
Days to Decision 260 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -