Cleared Traditional

K982354 - SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BOLT 80/140, TOB 6 WASHER MODELS 12MM 16MM 1M

K982354 is an FDA 510(k) clearance for SD TRANS-OSSEOUS FASTENER MODELS TOB 6 ..., manufactured by Special Devices, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K982354 · Special Devices, Inc. · Orthopedic device
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Nov 1998
Decision
140d
Days
Class 2
Risk

K982354 is an FDA 510(k) clearance for the SD TRANS-OSSEOUS FASTENER MODELS TOB 6 BOLT 32/50, TOB 6 BOLT 50/80, TOB 6 BO.... Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Special Devices, Inc. (Grass Valley, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 140 days - within the typical 510(k) review window.

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: 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 Special Devices, Inc. devices

FDA 510(k) Submission Details - K982354

510(k) Number K982354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date November 23, 1998
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
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 74
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K982354.
HEX BUTTON
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DEPUY ORTHOTECH SPIKED WASHER
K983906 · DePuy Orthopaedics, Inc. · Dec 1998
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K980944 · Synthes (Usa) · Apr 1998
ACUMED SUTURE WASHER
K965028 · Acu Med, Inc. · Mar 1997