The following data is part of a premarket notification filed by Stryker Orthopaedics with the FDA for Hipstar Femoral Stem.
Device ID | K051223 |
510k Number | K051223 |
Device Name: | HIPSTAR FEMORAL STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Contact | Tiffani Rogers |
Correspondent | Tiffani Rogers STRYKER ORTHOPAEDICS 325 Corporate Drive Mahwah, NJ 07430 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-12 |
Decision Date | 2006-05-10 |
Summary: | summary |