The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Ms-30 Femoral Stem.
Device ID | K993043 |
510k Number | K993043 |
Device Name: | MS-30 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 | Mitchell A Dhority |
Correspondent | Mitchell A Dhority 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 | 1999-09-10 |
Decision Date | 1999-12-02 |
Summary: | summary |