The following data is part of a premarket notification filed by Arthrotek, Inc. with the FDA for Ezloc Femoral Fixation Device.
| Device ID | K053461 |
| 510k Number | K053461 |
| Device Name: | EZLOC FEMORAL FIXATION DEVICE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304992269 | K053461 | 000 |
| 00880304992252 | K053461 | 000 |
| 00880304992245 | K053461 | 000 |
| 00880304469969 | K053461 | 000 |
| 00880304461307 | K053461 | 000 |
| 00880304460447 | K053461 | 000 |