The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Interlok Bio-modular Humeral Stems.
| Device ID | K032507 |
| 510k Number | K032507 |
| Device Name: | INTERLOK BIO-MODULAR HUMERAL STEMS |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-14 |
| Decision Date | 2003-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304213814 | K032507 | 000 |
| 00880304213685 | K032507 | 000 |
| 00880304213708 | K032507 | 000 |
| 00880304213715 | K032507 | 000 |
| 00880304213739 | K032507 | 000 |
| 00880304213746 | K032507 | 000 |
| 00880304213760 | K032507 | 000 |
| 00880304213784 | K032507 | 000 |
| 00880304213791 | K032507 | 000 |
| 00880304213807 | K032507 | 000 |
| 00880304204447 | K032507 | 000 |