The following data is part of a premarket notification filed by Arthronics, Inc. with the FDA for Futura Texture-trakked Total Hip Stem.
| Device ID | K921382 |
| 510k Number | K921382 |
| Device Name: | FUTURA TEXTURE-TRAKKED TOTAL HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | ARTHRONICS, INC. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| Contact | Ricardo J Heros |
| Correspondent | Ricardo J Heros ARTHRONICS, INC. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-23 |
| Decision Date | 1994-01-07 |