The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Resorbable Interference Screw.
| Device ID | K041274 |
| 510k Number | K041274 |
| Device Name: | RESORBABLE INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-12 |
| Decision Date | 2004-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304443280 | K041274 | 000 |
| 00880304421028 | K041274 | 000 |
| 00880304421011 | K041274 | 000 |
| 00880304421004 | K041274 | 000 |
| 00880304010901 | K041274 | 000 |
| 00880304007260 | K041274 | 000 |
| 00880304006676 | K041274 | 000 |
| 00880304005167 | K041274 | 000 |
| 00880304004023 | K041274 | 000 |
| 00880304003255 | K041274 | 000 |
| 00880304002814 | K041274 | 000 |
| 00880304421035 | K041274 | 000 |
| 00880304421042 | K041274 | 000 |
| 00880304421059 | K041274 | 000 |
| 00880304443273 | K041274 | 000 |
| 00880304443266 | K041274 | 000 |
| 00880304443259 | K041274 | 000 |
| 00880304443242 | K041274 | 000 |
| 00880304432543 | K041274 | 000 |
| 00880304432192 | K041274 | 000 |
| 00880304432185 | K041274 | 000 |
| 00880304432178 | K041274 | 000 |
| 00880304421073 | K041274 | 000 |
| 00880304421066 | K041274 | 000 |
| 00880304002012 | K041274 | 000 |