The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Ioi Bipolar Prosthesis.
Device ID | K873815 |
510k Number | K873815 |
Device Name: | IOI BIPOLAR PROSTHESIS |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
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 | KWY |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-21 |
Decision Date | 1987-10-28 |