The following data is part of a premarket notification filed by Signal Medical Corp. with the FDA for Symmetric Total Knee Aguments.
| Device ID | K100370 |
| 510k Number | K100370 |
| Device Name: | SYMMETRIC TOTAL KNEE AGUMENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SIGNAL MEDICAL CORP. 1000 DES PERES ROAD SUITE 140 St. Louis, MO 63131 |
| Contact | Brian Katerberg |
| Correspondent | Brian Katerberg SIGNAL MEDICAL CORP. 1000 DES PERES ROAD SUITE 140 St. Louis, MO 63131 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-12 |
| Decision Date | 2011-03-07 |
| Summary: | summary |