SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01— 510(k) K983757

Name: FDA 510(k) clearance K983757
Creator: U.S. Food and Drug Administration
Published: 1998-12-04

Substantially Equivalent

Syntec Scientific Corp.

FDA 510(k) clearance K983757 for SYNTEC-TAICHUNG NON-STERILE KNOWLES PIN, MODELS: FOR HEXAGONAL COLLAR: 2991-01/15,2992-01/15, FOR SQUARE COLLAR:29992-01, Substantially Equivalent on 1998-12-04. Applicant: Syntec Scientific Corp.. Device class: 2.

Clearance details

Applicant: Syntec Scientific Corp.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1998-10-23
Decision date: 1998-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chang Hua, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.