SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System— 510(k) K151885

Substantially Equivalent

Depuy Synthes, Inc.

FDA 510(k) clearance K151885 for SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System, Substantially Equivalent on 2015-09-03. Applicant: Depuy Synthes, Inc..

Clearance details

Applicant: Depuy Synthes, Inc.
Product code: Code NKG
Advisory panel: Orthopedic
Date received: 2015-07-09
Decision date: 2015-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.