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

Name: FDA 510(k) clearance K151885
Creator: U.S. Food and Drug Administration
Published: 2015-09-03

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.. Device class: 2.

Clearance details

Applicant: Depuy Synthes, Inc.
Product code: Code NKG
Device class: Class 2
Regulation: 21 CFR 888.3075
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 →

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