The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cofield Total Shoulder System.
| Device ID | K070565 |
| 510k Number | K070565 |
| Device Name: | COFIELD TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS RD Memphis, TN 38116 |
| Contact | Marlon D Ridley |
| Correspondent | Marlon D Ridley SMITH & NEPHEW, INC. 1450 E BROOKS RD Memphis, TN 38116 |
| Product Code | MBF |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-28 |
| Decision Date | 2007-05-18 |
| Summary: | summary |