The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Ms-30 Lateral Femoral Stem.
Device ID | K020713 |
510k Number | K020713 |
Device Name: | MS-30 LATERAL FEMORAL STEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
Applicant | SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Frances E Harrison |
Correspondent | Frances E Harrison SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | LZO |
CFR Regulation Number | 888.3353 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-05 |
Decision Date | 2002-05-14 |
Summary: | summary |