POWERGRIP(TM) COMPRESSION FIXATION DEVICE— 510(k) K950009

Name: FDA 510(k) clearance K950009
Creator: U.S. Food and Drug Administration
Published: 1995-08-18

Substantially Equivalent

Synvasive Technology, Inc.

FDA 510(k) clearance K950009 for POWERGRIP(TM) COMPRESSION FIXATION DEVICE, Substantially Equivalent on 1995-08-18. Applicant: Synvasive Technology, Inc.. Device class: 2.

Clearance details

Applicant: Synvasive Technology, Inc.
Product code: Code JDW
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1995-01-03
Decision date: 1995-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rancho Cordova, CA, US

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.