The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Provident Ii Hip Stems.
| Device ID | K201733 |
| 510k Number | K201733 |
| Device Name: | Provident II Hip Stems |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| Contact | Jennifer Antonacci |
| Correspondent | Jennifer Antonacci Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 |
| 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 | 2020-06-25 |
| Decision Date | 2021-07-14 |