The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Copeland Mb/ha Resurfacing Humeral Heads.
| Device ID | K010827 |
| 510k Number | K010827 |
| Device Name: | COPELAND MB/HA RESURFACING HUMERAL HEADS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara A Bailey |
| Correspondent | Sara A Bailey BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-20 |
| Decision Date | 2001-09-14 |
| Summary: | summary |