The following data is part of a premarket notification filed by Stelkast, Inc. with the FDA for Provident Ii Hip Stem.
| Device ID | K190276 |
| 510k Number | K190276 |
| Device Name: | Provident II Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | StelKast, Inc. 200 Hidden Valley Road Mcmurray, PA 15317 |
| Contact | David Stumpo |
| Correspondent | Hollace Rhodes Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20005 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQH |
| Subsequent Product Code | OQI |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-08 |
| Decision Date | 2019-03-08 |