The following data is part of a premarket notification filed by Howmedica Osteonics Corp. (aka Stryker Orthopaedics) with the FDA for Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment.
| Device ID | K190991 |
| 510k Number | K190991 |
| Device Name: | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | Howmedica Osteonics Corp. (aka Stryker Orthopaedics) 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Dipan Lad |
| Correspondent | Dipan Lad Howmedica Osteonics Corp. (aka Stryker Orthopaedics) 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327499940 | K190991 | 000 |
| 07613327381764 | K190991 | 000 |
| 07613327381771 | K190991 | 000 |
| 07613327381788 | K190991 | 000 |
| 07613327381795 | K190991 | 000 |
| 07613327459623 | K190991 | 000 |
| 07613327499858 | K190991 | 000 |
| 07613327499865 | K190991 | 000 |
| 07613327499872 | K190991 | 000 |
| 07613327499889 | K190991 | 000 |
| 07613327499896 | K190991 | 000 |
| 07613327499902 | K190991 | 000 |
| 07613327499919 | K190991 | 000 |
| 07613327499926 | K190991 | 000 |
| 07613327499933 | K190991 | 000 |
| 07613327381757 | K190991 | 000 |