The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Statak & Mini-statak Soft Tissue Attachment Device.
| Device ID | K926384 |
| 510k Number | K926384 |
| Device Name: | STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Victor E Butler |
| Correspondent | Victor E Butler ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-22 |
| Decision Date | 1993-11-16 |