The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Flexible Intramedullary Reamer.
| Device ID | K954915 |
| 510k Number | K954915 |
| Device Name: | FLEXIBLE INTRAMEDULLARY REAMER |
| Classification | Reamer |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | HTO |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-26 |
| Decision Date | 1995-12-28 |