510(k) K120165
K120165 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "INTRAOSSEOUS FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 17, 2012. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2012
- Date Received
- January 19, 2012
- 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