AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
FDA 510(k) clearance K192281 · decided 2019-11-20
Clearance details
- K-number
- K192281
- Device name
- AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2019-08-22
- Decision date
- 2019-11-20
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MRW
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.