The following data is part of a premarket notification filed by Tgm Medical, Inc. with the FDA for Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular Insert.
Device ID | K121636 |
510k Number | K121636 |
Device Name: | ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | TGM MEDICAL, INC. 5145 Golden Foothill Parkway SUITE 175 El Dorado Hills, CA 95762 |
Contact | Prakash Pai |
Correspondent | Prakash Pai TGM MEDICAL, INC. 5145 Golden Foothill Parkway SUITE 175 El Dorado Hills, CA 95762 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-04 |
Decision Date | 2012-10-24 |
Summary: | summary |