The following data is part of a premarket notification filed by Tgm Medical, Inc. with the FDA for Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, Insert.
| Device ID | K121509 |
| 510k Number | K121509 |
| Device Name: | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | TGM MEDICAL, INC. 5145 Golden Foothill Parkway Suite 175 & 180 El Dorado Hills, CA 95762 |
| Contact | Prakash Pai |
| Correspondent | Prakash Pai TGM MEDICAL, INC. 5145 Golden Foothill Parkway Suite 175 & 180 El Dorado Hills, CA 95762 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-21 |
| Decision Date | 2012-11-05 |
| Summary: | summary |