The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Microstrike And Allthread Peek Suture Anchor.
| Device ID | K060693 |
| 510k Number | K060693 |
| Device Name: | MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lester F Padilla |
| Correspondent | Lester F Padilla ARTHROTEK, INC. 56 EAST BELL DR. 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 | 2006-03-15 |
| Decision Date | 2006-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304476639 | K060693 | 000 |
| 00880304445055 | K060693 | 000 |
| 00880304449961 | K060693 | 000 |
| 00880304449978 | K060693 | 000 |
| 00880304451223 | K060693 | 000 |
| 00880304451230 | K060693 | 000 |
| 00880304454613 | K060693 | 000 |
| 00880304456099 | K060693 | 000 |
| 00880304471313 | K060693 | 000 |
| 00880304445048 | K060693 | 000 |