The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apr Ii Non-porous Hip Stem.
Device ID | K913208 |
510k Number | K913208 |
Device Name: | APR II NON-POROUS HIP STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Webb |
Correspondent | Webb 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 | 1991-07-19 |
Decision Date | 1991-10-11 |