510(k) K160461
K160461 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex iBalance BiCompartmental Arthroplasty System". The FDA issued a decision of Substantially Equivalent on April 12, 2016. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Arthrex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2016
- Date Received
- February 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3540
- Review Panel
- OR
- Submission Type