The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Acetabular Inserts Ioi Bipolar.
| Device ID | K935585 |
| 510k Number | K935585 |
| Device Name: | APR ACETABULAR INSERTS IOI BIPOLAR |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1995-12-13 |