The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Iiizarov Pulley System.
| Device ID | K042436 |
| 510k Number | K042436 |
| Device Name: | IIIZAROV PULLEY SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | John Reabe |
| Correspondent | John Reabe SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-08 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010470799 | K042436 | 000 |
| 03596010470775 | K042436 | 000 |
| 23596010470786 | K042436 | 000 |
| 23596010470762 | K042436 | 000 |
| 23596010470755 | K042436 | 000 |
| 03596010552877 | K042436 | 000 |
| 03596010552792 | K042436 | 000 |