The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Modification To: Biomet Humeral Cable Plates.
| Device ID | K013657 |
| 510k Number | K013657 |
| Device Name: | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2001-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304360662 | K013657 | 000 |
| 00880304360655 | K013657 | 000 |