510(k) K082172
K082172 is an FDA 510(k) premarket notification submitted by Mako Surgical Corporation for the device "MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 28, 2008. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520. Mako Surgical Corporation has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 2008
- Date Received
- August 1, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3520
- Review Panel
- OR
- Submission Type