The following data is part of a premarket notification filed by Howmedica Osteonics Corp., Dba Stryker Orthopaedics with the FDA for Acetabular Dome Hole Plug.
| Device ID | K220376 |
| 510k Number | K220376 |
| Device Name: | Acetabular Dome Hole Plug |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Lin Song |
| Correspondent | Lin Song Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-10 |
| Decision Date | 2022-03-09 |