The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Copeland Eas Humeral Resurfacing Heads.
| Device ID | K051843 |
| 510k Number | K051843 |
| Device Name: | COPELAND EAS HUMERAL RESURFACING HEADS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy Bickel Johnson |
| Correspondent | Tracy Bickel Johnson BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-07 |
| Decision Date | 2005-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304439962 | K051843 | 000 |
| 00880304439955 | K051843 | 000 |
| 00880304439948 | K051843 | 000 |
| 00880304439931 | K051843 | 000 |
| 00880304439924 | K051843 | 000 |
| 00880304439917 | K051843 | 000 |
| 00880304439900 | K051843 | 000 |
| 00880304439894 | K051843 | 000 |