510(k) K130832
K130832 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "ORTHOHELIX STAPLE SYSTEM". The FDA issued a decision of Substantially Equivalent on August 15, 2013. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2013
- Date Received
- March 26, 2013
- 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