The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Lactosorb L15 Screw Anchor With Lactocarbonate Suture.
| Device ID | K032072 |
| 510k Number | K032072 |
| Device Name: | LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel 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 | 2003-07-03 |
| Decision Date | 2003-10-01 |
| Summary: | summary |