The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Nonresorbable Centraloc Tibial Screw & Washer.
| Device ID | K051069 |
| 510k Number | K051069 |
| Device Name: | NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker ARTHROTEK, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-26 |
| Decision Date | 2005-06-29 |
| Summary: | summary |