K141550

Substantially Equivalent

INSTAFIX SHAPE MEMORY FIXATION SYSTEM

Applicant: Ot Medical
Product code: JDR
Advisory panel: Orthopedic
Date received: 2014-06-11
Decision date: 2014-07-11
Decision: Substantially Equivalent
Clearance type: Special
Location: King Of Prussia, PA, US

Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.