510(k) K162825
K162825 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "CAPTIVATE Compression Screws". The FDA issued a decision of Substantially Equivalent on May 1, 2017. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Globus Medical, Inc. has 173 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2017
- Date Received
- Oct 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)