SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System— 510(k) K151885
Substantially EquivalentDepuy 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
- Product code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Raynham, MA, US
Recent devices under product code NKG
view all- K254260 — The VEGA Cervical Screw System
- K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
- K254045 — CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
- K254165 — Infinity OCT System
- K252327 — CMORE® CT System; CMORE® CT System Navigated Instruments
Adverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
Source: openFDA MAUDE database, through . 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.