The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Collared Revision Femoral Component.
Device ID | K885192 |
510k Number | K885192 |
Device Name: | APR COLLARED REVISION FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
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 | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-16 |
Decision Date | 1989-06-22 |