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 Hip Applications.
| Device ID | K033341 |
| 510k Number | K033341 |
| Device Name: | SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Janet Johnson Akil |
| Correspondent | Janet Johnson Akil SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-17 |
| Decision Date | 2004-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010513977 | K033341 | 000 |
| 03596010513960 | K033341 | 000 |
| 03596010513953 | K033341 | 000 |
| 03596010513946 | K033341 | 000 |
| 03596010513984 | K033341 | 000 |