| Primary Device ID | 04547898432538 |
| NIH Device Record Key | b7fb3b90-ba71-408f-b2f7-47eff1620902 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Initia Total Hip System |
| Version Model Number | TJ39647-1 |
| Catalog Number | TJ39647-1 |
| Company DUNS | 690557624 |
| Company Name | KYOCERA CORPORATION |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com | |
| Phone | 909-557-2360 |
| kmti.info@kyocera.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04547898432538 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
[04547898432538]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-08 |
| Device Publish Date | 2021-11-30 |
| 04547898737541 | STD-HO LINER TRIAL 28-44 |
| 04547898737534 | STD-HO LINER TRIAL 40-72/74 |
| 04547898737527 | STD-HO LINER TRIAL 36-72/74 |
| 04547898737510 | STD-HO LINER TRIAL 32-72/74 |
| 04547898737503 | STD-HO LINER TRIAL 40-66/68/70 |
| 04547898737497 | STD-HO LINER TRIAL 36-66/68/70 |
| 04547898737480 | STD-HO LINER TRIAL 32-66/68/70 |
| 04547898737473 | STD-HO LINER TRIAL 40-60/62/64 |
| 04547898737466 | STD-HO LINER TRIAL 36-60/62/64 |
| 04547898737459 | STD-HO LINER TRIAL 32-60/62/64 |
| 04547898737442 | STD-HO LINER TRIAL 40-56/58 |
| 04547898737435 | STD-HO LINER TRIAL 36-56/58 |
| 04547898737428 | STD-HO LINER TRIAL 32-56/58 |
| 04547898737411 | STD-HO LINER TRIAL 36-52/54 |
| 04547898737404 | STD-HO LINER TRIAL 32-52/54 |
| 04547898737398 | STD-HO LINER TRIAL 36-50 |
| 04547898737381 | STD-HO LINER TRIAL 32-50 |
| 04547898737374 | STD-HO LINER TRIAL 28-50 |
| 04547898737367 | STD-HO LINER TRIAL 32-48 |
| 04547898737350 | STD-HO LINER TRIAL 28-48 |
| 04547898737343 | STD-HO LINER TRIAL 32-46 |
| 04547898737336 | STD-HO LINER TRIAL 28-46 |
| 04547898737312 | STD LINER TRIAL 28-44 |
| 04547898737305 | STD LINER TRIAL 40-72/74 |
| 04547898737299 | STD LINER TRIAL 36-72/74 |
| 04547898737282 | STD LINER TRIAL 32-72/74 |
| 04547898737275 | STD LINER TRIAL 40-66/68/70 |
| 04547898737268 | STD LINER TRIAL 36-66/68/70 |
| 04547898737251 | STD LINER TRIAL 32-66/68/70 |
| 04547898737244 | STD LINER TRIAL 40-60/62/64 |
| 04547898737237 | STD LINER TRIAL 36-60/62/64 |
| 04547898737220 | STD LINER TRIAL 32-60/62/64 |
| 04547898737213 | STD LINER TRIAL 40-56/58 |
| 04547898737206 | STD LINER TRIAL 36-56/58 |
| 04547898737190 | STD LINER TRIAL 32-56/58 |
| 04547898737183 | STD LINER TRIAL 36-52/54 |
| 04547898737176 | STD LINER TRIAL 32-52/54 |
| 04547898737169 | STD LINER TRIAL 36-50 |
| 04547898737152 | STD LINER TRIAL 32-50 |
| 04547898737145 | STD LINER TRIAL 28-50 |
| 04547898737138 | STD LINER TRIAL 32-48 |
| 04547898737121 | STD LINER TRIAL 28-48 |
| 04547898737114 | STD LINER TRIAL 32-46 |
| 04547898737107 | STD LINER TRIAL 28-46 |
| 04547898736933 | INITIA BROACH 10 |
| 04547898736926 | INITIA BROACH 9 |
| 04547898736919 | MALLET |
| 04547898736902 | FEMORAL BROACH TRAY |
| 04547898736513 | MX-HO LINER TRIAL 28-44 |
| 04547898736506 | MX-HO LINER TRIAL 28-50 |