510(k) K131635
K131635 is an FDA 510(k) premarket notification submitted by Rotation Medical, Inc. for the device "ROTATION MEDICAL BONE STAPLE (RMB STAPLE)". The FDA issued a decision of Substantially Equivalent on August 29, 2013. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Rotation Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2013
- Date Received
- June 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type