The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd. with the FDA for Mets Modular Total Femur.
| Device ID | K121055 |
| 510k Number | K121055 |
| Device Name: | METS MODULAR TOTAL FEMUR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | STANMORE IMPLANTS WORLDWIDE LTD. 690 CANTON STREET SUITE 302 Westwood, MA 02090 |
| Contact | Nancy C Macdonald |
| Correspondent | Nancy C Macdonald STANMORE IMPLANTS WORLDWIDE LTD. 690 CANTON STREET SUITE 302 Westwood, MA 02090 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-09-19 |
| Summary: | summary |