510(k) K180480
K180480 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "ATEC Universal Spacer System". The FDA issued a decision of Substantially Equivalent on May 31, 2018. The device falls under product code PHM (Intervertebral Fusion Device With Bone Graft, Thoracic), a Class II device regulated under 21 CFR 888.3080. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2018
- Date Received
- February 23, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Thoracic
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
Intended to stabilize thoracic spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.