The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Orthopaedic Cabling System.
| Device ID | K031162 |
| 510k Number | K031162 |
| Device Name: | SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kanu Vadodaria |
| Correspondent | Kanu Vadodaria SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010525321 | K031162 | 000 |
| 03596010485755 | K031162 | 000 |
| 03596010485786 | K031162 | 000 |
| 03596010485809 | K031162 | 000 |
| 03596010485816 | K031162 | 000 |
| 03596010485823 | K031162 | 000 |
| 03596010525338 | K031162 | 000 |
| 03596010485731 | K031162 | 000 |
| 03596010525291 | K031162 | 000 |
| 03596010485724 | K031162 | 000 |
| 03596010485779 | K031162 | 000 |
| 03596010485793 | K031162 | 000 |
| 03596010525307 | K031162 | 000 |
| 03596010525314 | K031162 | 000 |
| 03596010485748 | K031162 | 000 |