The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Sulzer Orthopedics Converge Acetabular System.
| Device ID | K012961 |
| 510k Number | K012961 |
| Device Name: | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-04 |
| Decision Date | 2001-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024172050 | K012961 | 000 |
| 00889024171909 | K012961 | 000 |
| 00889024171893 | K012961 | 000 |
| 00889024171886 | K012961 | 000 |
| 00889024171879 | K012961 | 000 |
| 00889024171862 | K012961 | 000 |
| 00889024171855 | K012961 | 000 |
| 00889024171848 | K012961 | 000 |
| 00889024171831 | K012961 | 000 |
| 00889024171824 | K012961 | 000 |
| 00889024171817 | K012961 | 000 |
| 00889024171800 | K012961 | 000 |
| 00889024171794 | K012961 | 000 |
| 00889024171916 | K012961 | 000 |
| 00889024171923 | K012961 | 000 |
| 00889024172043 | K012961 | 000 |
| 00889024172036 | K012961 | 000 |
| 00889024172029 | K012961 | 000 |
| 00889024172012 | K012961 | 000 |
| 00889024172005 | K012961 | 000 |
| 00889024171992 | K012961 | 000 |
| 00889024171985 | K012961 | 000 |
| 00889024171978 | K012961 | 000 |
| 00889024171961 | K012961 | 000 |
| 00889024171954 | K012961 | 000 |
| 00889024171947 | K012961 | 000 |
| 00889024171930 | K012961 | 000 |
| 00889024171787 | K012961 | 000 |