SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25— 510(k) K984543

Substantially Equivalent

Syntec Scientific Corp.

FDA 510(k) clearance K984543 for SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25, Substantially Equivalent on 1999-03-01. Applicant: Syntec Scientific Corp..

Clearance details

Applicant: Syntec Scientific Corp.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1998-12-21
Decision date: 1999-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang Hua, TW

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.