The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Image Guided Surgical Instruments For Knee Applications.
| Device ID | K012938 |
| 510k Number | K012938 |
| Device Name: | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Trude C Naff |
| Correspondent | Trude C Naff SMITH & NEPHEW, INC. 1450 BROOKS RD. 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 | 2001-08-31 |
| Decision Date | 2002-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556074930 | K012938 | 000 |
| 03596010482037 | K012938 | 000 |
| 03596010482044 | K012938 | 000 |
| 03596010482051 | K012938 | 000 |
| 03596010482068 | K012938 | 000 |
| 03596010482075 | K012938 | 000 |
| 03596010482327 | K012938 | 000 |
| 03596010482334 | K012938 | 000 |
| 03596010482396 | K012938 | 000 |
| 03596010592866 | K012938 | 000 |
| 03596010593108 | K012938 | 000 |
| 03596010593122 | K012938 | 000 |
| 00885556074176 | K012938 | 000 |
| 00885556074268 | K012938 | 000 |
| 00885556074329 | K012938 | 000 |
| 00885556074527 | K012938 | 000 |
| 03596010471123 | K012938 | 000 |