510(k) K182284
K182284 is an FDA 510(k) premarket notification submitted by Tyber Medical, LLC for the device "Tyber Medical PT Interbody Spacer". The FDA issued a decision of Substantially Equivalent on Jan 18, 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. Tyber Medical, LLC has 30 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2019
- Date Received
- Aug 23, 2018
- 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.