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 |