The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Bipolar Radial Head Prosthesis.
| Device ID | K994041 |
| 510k Number | K994041 |
| Device Name: | TORNIER BIPOLAR RADIAL HEAD PROSTHESIS |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | TORNIER, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TORNIER, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 2000-08-31 |
| Summary: | summary |