510(k) K183603
K183603 is an FDA 510(k) premarket notification submitted by Exsomed Corporation for the device "INnate Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on Mar 12, 2019. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Exsomed Corporation has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 12, 2019
- Date Received
- Dec 26, 2018
- Clearance Type
- Special
- 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)