The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Resorbable Screw Anchor.
| Device ID | K012872 |
| 510k Number | K012872 |
| Device Name: | RESORBABLE SCREW ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHROTEK, INC. 56 EAST BELLE DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz ARTHROTEK, INC. 56 EAST BELLE DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-27 |
| Decision Date | 2001-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304466500 | K012872 | 000 |
| 00880304420953 | K012872 | 000 |
| 00880304420946 | K012872 | 000 |
| 00880304420939 | K012872 | 000 |
| 00887868238017 | K012872 | 000 |