The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Resorbable Soft Tissue Attachment Device.
| Device ID | K961789 |
| 510k Number | K961789 |
| Device Name: | RESORBABLE SOFT TISSUE ATTACHMENT DEVICE |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynette Whitaker |
| Correspondent | Lynette Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-08-01 |
| Summary: | summary |