The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Orthoblend Powered Bone Mill.
| Device ID | K860356 |
| 510k Number | K860356 |
| Device Name: | ORTHOBLEND POWERED BONE MILL |
| Classification | Bone Mill |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Henry A Quello |
| Correspondent | Henry A Quello ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | LYS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-30 |
| Decision Date | 1986-07-08 |