The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Femoral Hook.
| Device ID | K041261 |
| 510k Number | K041261 |
| Device Name: | FEMORAL HOOK |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-11 |
| Decision Date | 2004-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304457362 | K041261 | 000 |
| 00880304457355 | K041261 | 000 |
| 00880304457348 | K041261 | 000 |
| 00880304457331 | K041261 | 000 |
| 00880304457324 | K041261 | 000 |
| 00880304457317 | K041261 | 000 |