The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Total Hip Prothesis Femoral Component.
Device ID | K923734 |
510k Number | K923734 |
Device Name: | TOTAL HIP PROTHESIS FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Joann Ringer |
Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1993-06-14 |