TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM— 510(k) K981714

Substantially Equivalent

Acromed Corp.

FDA 510(k) clearance K981714 for TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM, Substantially Equivalent on 1998-06-30. Applicant: Acromed Corp..

Clearance details

Applicant: Acromed Corp.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1998-05-15
Decision date: 1998-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.