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 |