The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Image Surgical Instruments For Trauma Applications.
| Device ID | K021815 |
| 510k Number | K021815 |
| Device Name: | SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Contact | Gino J Rouss |
| Correspondent | Gino J Rouss SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2002-10-17 |
| Summary: | summary |