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 |