The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Titan Reverse Shoulder System.
| Device ID | K173717 |
| 510k Number | K173717 |
| Device Name: | Integra TITAN Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Integra LifeSciences Corporation 8700 Cameron Road Suite 100 Austin, TX 78754 |
| Contact | Kathleen Mcguire |
| Correspondent | Blesson Abraham Integra LifeSciences Corporation 8700 Cameron Road Suite 100 Austin, TX 78754 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-05 |
| Decision Date | 2018-06-21 |
| Summary: | summary |