The following data is part of a premarket notification filed by O'tec Corp. with the FDA for Futura Femoral Hip Stem.
| Device ID | K910093 |
| 510k Number | K910093 |
| Device Name: | FUTURA FEMORAL HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| Contact | Ricardo Heros |
| Correspondent | Ricardo Heros O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-07-01 |