The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Knee Fusion Nail.
| Device ID | K061783 |
| 510k Number | K061783 |
| Device Name: | KNEE FUSION NAIL |
| Classification | Nail, Fixation, Bone |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | John Reabe |
| Correspondent | John Reabe SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-26 |
| Decision Date | 2006-08-10 |
| Summary: | summary |