The following data is part of a premarket notification filed by Tgm Medical, Inc. with the FDA for Tgm Biolox Delta Ceramic Heads.
| Device ID | K150576 |
| 510k Number | K150576 |
| Device Name: | TGM Biolox Delta Ceramic Heads |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | TGM MEDICAL, INC. 5145 Golden Foothill Parkway Suite 175/180 El Dorado Hills, CA 95762 |
| Contact | Gordon Smith |
| Correspondent | Kellen Hills Orchid Design 4600 E Shelby Dr Memphis, TN 38118 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2015-09-09 |
| Summary: | summary |