510(k) K171365
K171365 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Knee Systems". The FDA issued a decision of Substantially Equivalent on Nov 7, 2017. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Arthrex, Inc. has 352 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 7, 2017
- Date Received
- May 9, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3565
- Review Panel
- OR
- Submission Type
- 510(k)