The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for True/fit Femoral Intramedullary Rod System.
| Device ID | K961360 |
| 510k Number | K961360 |
| Device Name: | TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Contact | Ashley Bock |
| Correspondent | Ashley Bock ENCORE ORTHOPEDICS, INC. 8900 SHOAL CREEK BLVD., BLDG. 300 Austin, TX 78757 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1997-03-13 |
| Summary: | summary |