510(k) K191354
K191354 is an FDA 510(k) premarket notification submitted by Zavation Medical Products, LLC for the device "Ti3Z Cervical Interbody System". The FDA issued a decision of Substantially Equivalent on Sep 9, 2019. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Zavation Medical Products, LLC has 30 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 2019
- Date Received
- May 21, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.