The following data is part of a premarket notification filed by Mako Surgical Corp. with the FDA for Mako Surgical Corporation Unicondylar Knee Implant System Iii.
Device ID | K082081 |
510k Number | K082081 |
Device Name: | MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III |
Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
Applicant | MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale, FL 33317 |
Contact | William F Tapia |
Correspondent | William F Tapia MAKO SURGICAL CORP. 2555 DAVIE RD. Fort Lauderdale, FL 33317 |
Product Code | HSX |
CFR Regulation Number | 888.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-23 |
Decision Date | 2008-10-15 |
Summary: | summary |