510(k) K130380
K130380 is an FDA 510(k) premarket notification submitted by Orthosensor, Inc. for the device "ORTHOSENSOR KNEE BALANCER". The FDA issued a decision of Substantially Equivalent on June 13, 2013. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthosensor, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2013
- Date Received
- February 14, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoperative Orthopedic Joint Assessment Aid
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- OR
- Submission Type
Measurement and interpretation of orthopedic joint information.