INSTAFIX SHAPE MEMORY FIXATION SYSTEM— 510(k) K141550

Name: FDA 510(k) clearance K141550
Creator: U.S. Food and Drug Administration
Published: 2014-07-11

Substantially Equivalent

Ot Medical

FDA 510(k) clearance K141550 for INSTAFIX SHAPE MEMORY FIXATION SYSTEM, Substantially Equivalent on 2014-07-11. Applicant: Ot Medical. Device class: 2.

Clearance details

Applicant: Ot Medical
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
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

Download summary PDF View on FDA.gov ↗

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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.