The following data is part of a premarket notification filed by Sulzer Medica with the FDA for Apr Metasul Acetabular Insert.
| Device ID | K993569 |
| 510k Number | K993569 |
| Device Name: | APR METASUL ACETABULAR INSERT |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | SULZER MEDICA 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER MEDICA 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 1999-12-01 |
| Summary: | summary |