510(k) K163602
K163602 is an FDA 510(k) premarket notification submitted by Orbbo Surgical, LLC for the device "Kepler I Cervical Plate System". The FDA issued a decision of Substantially Equivalent on Feb 16, 2017. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Orbbo Surgical, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 2017
- Date Received
- Dec 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Spinal Intervertebral Body
- Device Class
- Class II
- Regulation Number
- 888.3060
- Review Panel
- OR
- Submission Type
- 510(k)