The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Modified Anatomic Porous Replacement Apr Acetabula.
| Device ID | K850793 |
| 510k Number | K850793 |
| Device Name: | MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| 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 | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-26 |
| Decision Date | 1985-05-09 |