The following data is part of a premarket notification filed by Tgm Medical with the FDA for Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip System, Acetabular Shell, Helicon.
| Device ID | K111472 |
| 510k Number | K111472 |
| Device Name: | HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | TGM MEDICAL 5145 GOLDEN FOOTHILL PARKWAY SUITE 175 & 180 El Dorado, CA 95762 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane TGM MEDICAL 5145 GOLDEN FOOTHILL PARKWAY SUITE 175 & 180 El Dorado, 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 | 2011-05-27 |
| Decision Date | 2011-09-06 |
| Summary: | summary |