The following data is part of a premarket notification filed by Stanmore Implants Worldwide Ltd with the FDA for Mets Modular Distal Femur.
| Device ID | K121029 |
| 510k Number | K121029 |
| Device Name: | METS MODULAR DISTAL FEMUR |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| 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 | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-05 |
| Decision Date | 2012-09-19 |
| Summary: | summary |