The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Ti - Screw Anchor Sp.
| Device ID | K042460 |
| 510k Number | K042460 |
| Device Name: | TI - SCREW ANCHOR SP |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| Subsequent Product Code | GAS |
| Subsequent Product Code | GAT |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-10 |
| Decision Date | 2004-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304563698 | K042460 | 000 |
| 00880304453432 | K042460 | 000 |
| 00880304453449 | K042460 | 000 |
| 00880304453463 | K042460 | 000 |
| 00880304453470 | K042460 | 000 |
| 00880304464186 | K042460 | 000 |
| 00880304464193 | K042460 | 000 |
| 00880304464315 | K042460 | 000 |
| 00880304464544 | K042460 | 000 |
| 00880304464896 | K042460 | 000 |
| 00880304465466 | K042460 | 000 |
| 00880304563681 | K042460 | 000 |
| 00880304444263 | K042460 | 000 |