510(k) K153395
K153395 is an FDA 510(k) premarket notification submitted by In2bones Sas for the device "OS2-C Compression Staple". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones Sas has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2016
- Date Received
- November 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type