The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Sureshot Distal Targeting System V4.0 Trauma Interface.
| Device ID | K170977 |
| 510k Number | K170977 |
| Device Name: | SURESHOT Distal Targeting System V4.0 Trauma Interface |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Smith & Nephew, Inc. 1450 Brooks Rd Memphis, TN 38116 |
| Contact | Allison Chan |
| Correspondent | Allison Chan Smith & Nephew, Inc. 1450 Brooks Rd 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 | 2017-04-03 |
| Decision Date | 2017-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556584675 | K170977 | 000 |
| 00885556584644 | K170977 | 000 |