The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Reunion Bone Screw System.
| Device ID | K951389 |
| 510k Number | K951389 |
| Device Name: | REUNION BONE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Contact | Jeff Cobb |
| Correspondent | Jeff Cobb SMITH & NEPHEW RICHARDS, INC. 1450 E. BROOKS RD. Memphis, TN 38116 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-07-24 |