ANATOMIC PEEK CERVICAL FUSION SYSTEM— 510(k) K112444

Substantially Equivalent

Medtronic Sofamor Danck USA, Inc.

FDA 510(k) clearance K112444 for ANATOMIC PEEK CERVICAL FUSION SYSTEM, Substantially Equivalent on 2011-11-15. Applicant: Medtronic Sofamor Danck USA, Inc..

Clearance details

Applicant: Medtronic Sofamor Danck USA, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2011-08-24
Decision date: 2011-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, 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.