The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Contour Ha Coated Reconstruction Ring.
| Device ID | K040680 |
| 510k Number | K040680 |
| Device Name: | CONTOUR HA COATED RECONSTRUCTION RING |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Contact | John Reabe |
| Correspondent | John Reabe SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-16 |
| Decision Date | 2004-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556049242 | K040680 | 000 |
| 00885556048771 | K040680 | 000 |
| 00885556048610 | K040680 | 000 |
| 00885556048528 | K040680 | 000 |
| 00885556048207 | K040680 | 000 |