The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for 2.8 & 3.5mm Lactoscrew Suture Anchors.
| Device ID | K061801 |
| 510k Number | K061801 |
| Device Name: | 2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS |
| Classification | Staple, Fixation, Bone |
| Applicant | ARTHROTEK, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander ARTHROTEK, INC. 56 EAST BELL DR. 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 | 2006-06-26 |
| Decision Date | 2006-08-07 |
| Summary: | summary |