The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Exeter Centralizer, Exeter 2.5mm Plug.
| Device ID | K191414 |
| 510k Number | K191414 |
| Device Name: | EXETER Centralizer, EXETER 2.5mm Plug |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Denise Daugert |
| Correspondent | Denise Daugert Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2019-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540166715 | K191414 | 000 |