The following data is part of a premarket notification filed by Smith & Newphew, Inc with the FDA for Smith & Nephew, Inc. Sureshot Distal Targeting System V2.0.2.
| Device ID | K102967 |
| 510k Number | K102967 |
| Device Name: | SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | SMITH & NEWPHEW, INC 1450 E. BROOKS ROAD Memphis, TN 38116 |
| Contact | Shereen Myers |
| Correspondent | Shereen Myers SMITH & NEWPHEW, INC 1450 E. BROOKS ROAD Memphis, TN 38116 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-05 |
| Decision Date | 2010-11-04 |
| Summary: | summary |