The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Inter-op Durasul Acetabular Inserts/cocr Femoral Heads.
| Device ID | K993259 |
| 510k Number | K993259 |
| Device Name: | INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-29 |
| Decision Date | 2000-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024163522 | K993259 | 000 |
| 00889024168954 | K993259 | 000 |
| 00889024168947 | K993259 | 000 |
| 00889024168930 | K993259 | 000 |
| 00889024168923 | K993259 | 000 |
| 00889024168916 | K993259 | 000 |
| 00889024168909 | K993259 | 000 |
| 00889024168893 | K993259 | 000 |
| 00889024168886 | K993259 | 000 |
| 00889024168879 | K993259 | 000 |
| 00889024168862 | K993259 | 000 |
| 00889024168855 | K993259 | 000 |
| 00889024168848 | K993259 | 000 |
| 00889024168831 | K993259 | 000 |
| 00889024168480 | K993259 | 000 |
| 00889024168961 | K993259 | 000 |
| 00889024168978 | K993259 | 000 |
| 00889024163492 | K993259 | 000 |
| 00889024163485 | K993259 | 000 |
| 00889024163515 | K993259 | 000 |
| 00889024163508 | K993259 | 000 |
| 00889024169074 | K993259 | 000 |
| 00889024169067 | K993259 | 000 |
| 00889024169050 | K993259 | 000 |
| 00889024169043 | K993259 | 000 |
| 00889024169036 | K993259 | 000 |
| 00889024169029 | K993259 | 000 |
| 00889024169012 | K993259 | 000 |
| 00889024169005 | K993259 | 000 |
| 00889024168992 | K993259 | 000 |
| 00889024168985 | K993259 | 000 |
| 00889024168473 | K993259 | 000 |