The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Conformis Metal Backed Tibial Component(mbt).
| Device ID | K063432 |
| 510k Number | K063432 |
| Device Name: | CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT) |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | CONFORMIS, INC. 323-C VINTAGE PARK DR. Foster City, CA 94404 |
| Contact | Michael Sharp |
| Correspondent | Michael Sharp CONFORMIS, INC. 323-C VINTAGE PARK DR. Foster City, CA 94404 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-03-16 |
| Summary: | summary |