Cleared Traditional

K150359 - Tensyn Plug

K150359 is an FDA 510(k) clearance for Tensyn Plug, manufactured by Dallen Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K150359 · Dallen Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
84d
Days
Class 2
Risk

K150359 is an FDA 510(k) clearance for the Tensyn Plug. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Dallen Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 7, 2015 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. 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.

FDA 510(k) Submission Details - K150359

510(k) Number K150359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2015
Decision Date May 07, 2015
Days to Decision 84 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HTN Washer, Bolt Nut

All 91
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K150359.
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