The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Sureshot Distal Targeting System V3.0.
| Device ID | K130748 |
| 510k Number | K130748 |
| Device Name: | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Bradley Heil |
| Correspondent | Bradley Heil SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-19 |
| Decision Date | 2013-08-04 |
| Summary: | summary |