The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Discovery Elbow.
| Device ID | K013042 |
| 510k Number | K013042 |
| Device Name: | DISCOVERY ELBOW |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2001-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446254546 | K013042 | 000 |
| 00190446254386 | K013042 | 000 |
| 00190446254393 | K013042 | 000 |
| 00190446254409 | K013042 | 000 |
| 00190446254416 | K013042 | 000 |
| 00190446254423 | K013042 | 000 |
| 00190446254430 | K013042 | 000 |
| 00190446254447 | K013042 | 000 |
| 00190446254454 | K013042 | 000 |
| 00190446254461 | K013042 | 000 |
| 00190446254478 | K013042 | 000 |
| 00190446254485 | K013042 | 000 |
| 00190446254492 | K013042 | 000 |
| 00190446254508 | K013042 | 000 |
| 00190446254515 | K013042 | 000 |
| 00190446254522 | K013042 | 000 |
| 00190446254539 | K013042 | 000 |
| 00190446254379 | K013042 | 000 |