510(k) K213219
K213219 is an FDA 510(k) premarket notification submitted by Vy Spine, LLC for the device "Vy Spine VyWasher Buttress System". The FDA issued a decision of Substantially Equivalent on December 23, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Vy Spine, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 23, 2021
- Date Received
- September 29, 2021
- 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