510(k) K173521
K173521 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "SeaSpine Cabo ACP (Anterior Cervical Plate) System". The FDA issued a decision of Substantially Equivalent on Jan 24, 2018. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. SeaSpine Orthopedics Corporation has 66 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 24, 2018
- Date Received
- Nov 14, 2017
- 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
- 510(k)