TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF— 510(k) K130573

Substantially Equivalent

Tyber Medical, LLC

FDA 510(k) clearance K130573 for TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF, Substantially Equivalent on 2013-09-30. Applicant: Tyber Medical, LLC.

Clearance details

Applicant: Tyber Medical, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2013-03-04
Decision date: 2013-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

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Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.