BIOMECHANIC LOW-PROFILE CABLE SYSTEM— 510(k) K951844

Substantially Equivalent for Some Indications

Biomechanic, Inc.

FDA 510(k) clearance K951844 for BIOMECHANIC LOW-PROFILE CABLE SYSTEM, Substantially Equivalent for Some Indications on 1995-07-13. Applicant: Biomechanic, Inc..

Clearance details

Applicant: Biomechanic, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1995-04-20
Decision date: 1995-07-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Creve Coeur, MO, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.