510(k) K112675
K112675 is an FDA 510(k) premarket notification submitted by Arrowhead Medical Device Technologies, LLC for the device "ARROW-LOK DIGITAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 12, 2011. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Arrowhead Medical Device Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 12, 2011
- Date Received
- Sep 14, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type