510(k) K161809
K161809 is an FDA 510(k) premarket notification submitted by Precision Spine, Inc. for the device "ShurFit CpTi-HA ACIF Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on December 6, 2016. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Precision Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2016
- Date Received
- July 1, 2016
- 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
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.