The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Resorbable Soft Tissue Attachment Device.
| Device ID | K950275 |
| 510k Number | K950275 |
| 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 | Whitaker |
| Correspondent | Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-23 |
| Decision Date | 1995-11-07 |