The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Most Options System.
| Device ID | K013031 |
| 510k Number | K013031 |
| Device Name: | MOST OPTIONS SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2001-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024248267 | K013031 | 000 |
| 00889024247796 | K013031 | 000 |
| 00889024247802 | K013031 | 000 |
| 00889024247819 | K013031 | 000 |
| 00889024247826 | K013031 | 000 |
| 00889024247833 | K013031 | 000 |
| 00889024247840 | K013031 | 000 |
| 00889024247857 | K013031 | 000 |
| 00889024247864 | K013031 | 000 |
| 00889024247789 | K013031 | 000 |
| 00889024247772 | K013031 | 000 |
| 00889024248304 | K013031 | 000 |
| 00889024262263 | K013031 | 000 |
| 00889024262270 | K013031 | 000 |
| 00889024262287 | K013031 | 000 |
| 00889024262294 | K013031 | 000 |
| 00889024262300 | K013031 | 000 |
| 00889024262317 | K013031 | 000 |
| 00889024262324 | K013031 | 000 |
| 00889024247871 | K013031 | 000 |
| 00889024247888 | K013031 | 000 |
| 00889024247895 | K013031 | 000 |
| 00889024248007 | K013031 | 000 |
| 00889024248014 | K013031 | 000 |
| 00889024248021 | K013031 | 000 |
| 00889024248038 | K013031 | 000 |
| 00889024252431 | K013031 | 000 |
| 00889024252448 | K013031 | 000 |
| 00889024252455 | K013031 | 000 |
| 00889024252462 | K013031 | 000 |
| 00889024247994 | K013031 | 000 |
| 00889024247987 | K013031 | 000 |
| 00889024247901 | K013031 | 000 |
| 00889024247918 | K013031 | 000 |
| 00889024247925 | K013031 | 000 |
| 00889024247932 | K013031 | 000 |
| 00889024247949 | K013031 | 000 |
| 00889024247956 | K013031 | 000 |
| 00889024247963 | K013031 | 000 |
| 00889024247970 | K013031 | 000 |
| 00889024252523 | K013031 | 000 |