The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Apr(tm) Ii Femoral Component.
| Device ID | K890450 |
| 510k Number | K890450 |
| Device Name: | INTERMEDICS APR(TM) II FEMORAL COMPONENT |
| Classification | Mesh, Surgical, Acetabular, Hip, Prosthesis |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Thomas L Craig |
| Correspondent | Thomas L Craig INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | JDJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-08-09 |