MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System— 510(k) K190895
Substantially EquivalentMedos International SARL
FDA 510(k) clearance K190895 for MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System, Substantially Equivalent on 2019-07-18. Applicant: Medos International SARL. Device class: 2.
Clearance details
- Applicant
- Medos International SARL
- 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
- Le Locle, CH
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
More clearances from Medos International SARL
view allAdverse 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.