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— 510(k) K982354

Substantially Equivalent

Special Devices, Inc.

FDA 510(k) clearance K982354 for 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, Substantially Equivalent on 1998-11-23. Applicant: Special Devices, Inc..

Clearance details

Applicant: Special Devices, Inc.
Product code: Code HTN
Advisory panel: Orthopedic
Date received: 1998-07-06
Decision date: 1998-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Valley, CA, US

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Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.