The following data is part of a premarket notification filed by Stanmore Inc. with the FDA for Patient Specific Smiles Total Knee Replacement.
| Device ID | K140900 |
| 510k Number | K140900 |
| Device Name: | PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | STANMORE INC. 10 CORDAGE ROAD PARK CIRCLE, SUITE 200 Plymouth, MA 02360 |
| Contact | Samantha Shelley |
| Correspondent | Dan Clarke STANMORE INC. 210 CENTENNIAL AVENUE CENTENNIAL PARK Elstree, GB Wd6 3sj |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-08 |
| Decision Date | 2015-02-12 |
| Summary: | summary |