The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Allthread Lactosorb Suture Anchor.
| Device ID | K061389 |
| 510k Number | K061389 |
| Device Name: | ALLTHREAD LACTOSORB SUTURE ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lester F Padilla |
| Correspondent | Lester F Padilla ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-18 |
| Decision Date | 2006-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304563827 | K061389 | 000 |
| 00880304481206 | K061389 | 000 |
| 00880304450325 | K061389 | 000 |
| 00880304445284 | K061389 | 000 |