WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS— 510(k) K033112

Substantially Equivalent

Hand Biomechanics Lab, Inc.

FDA 510(k) clearance K033112 for WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347, CFD-347-NS, Substantially Equivalent on 2003-11-05. Applicant: Hand Biomechanics Lab, Inc..

Clearance details

Applicant: Hand Biomechanics Lab, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2003-09-30
Decision date: 2003-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.