| Primary Device ID | 00822409105502 |
| NIH Device Record Key | 4fd1aa45-c8e7-4060-98e5-ce1c3396301a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | n/a |
| Version Model Number | 861-1101 |
| Company DUNS | 876542390 |
| Company Name | Ortho Development Corporation |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com | |
| Phone | +1(801)553-9991 |
| customerservice@odev.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00822409105502 [Primary] |
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
[00822409105502]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-03 |
| Device Publish Date | 2021-12-24 |
| 00822409045082 | Straight Anterior Broach Handle |
| 00822409044474 | CR Insert Trials Size 6 |
| 00822409044467 | CR Insert Trials Size 6 |
| 00822409044450 | CR Insert Trials Size 6 |
| 00822409044443 | CR Insert Trials Size 6 |
| 00822409044436 | CR Insert Trials Size 5 |
| 00822409044429 | CR Insert Trials Size 5 |
| 00822409044412 | CR Insert Trials Size 5 |
| 00822409044405 | CR Insert Trials Size 5 |
| 00822409044399 | CR Insert Trials Size 4 |
| 00822409044382 | CR Insert Trials Size 4 |
| 00822409044375 | CR Insert Trials Size 4 |
| 00822409044368 | CR Insert Trials Size 4 |
| 00822409044351 | CR Insert Trials Size 3 |
| 00822409044344 | CR Insert Trials Size 3 |
| 00822409044337 | CR Insert Trials Size 3 |
| 00822409044320 | CR Insert Trials Size 3 |
| 00822409044313 | CR Insert Trials Size 2 |
| 00822409044306 | CR Insert Trials Size 2 |
| 00822409044290 | CR Insert Trials Size 2 |
| 00822409044283 | CR Insert Trials Size 2 |
| 00822409044276 | Wingnut Patella Reaming Handle |
| 00822409046546 | Single Offset Broach Handle |
| 00822409046539 | 2mm Tibial Recut Block |
| 00822409071630 | Threaded Collarless Pin 50mm |
| 00822409071623 | Threaded Collared Pin 50mm |
| 00822409071272 | TibTrialSpacer Lg Height 30mm |
| 00822409071265 | TibTrialSpacer Lg Height 25mm |
| 00822409071258 | TibTrialSpacer Lg Height 20mm |
| 00822409071241 | TibTrialSpacer Lg Height18mm |
| 00822409071234 | TibTrialSpacer Lg Height16mm |
| 00822409071227 | TibTrialSpacer Lg Height14mm |
| 00822409071210 | TibTrialSpacer Lg Height12mm |
| 00822409071203 | TibTrialSpacer Lg Height10mm |
| 00822409071197 | TibTrialSpacer Med Height30mm |
| 00822409071180 | TibTrialSpacer Med Height25mm |
| 00822409071173 | TibTrialSpacer Med Height20mm |
| 00822409071166 | TibTrialSpacer Med Height18mm |
| 00822409071159 | TibTrialSpacer Med Height16mm |
| 00822409071142 | TibTrialSpacer Med Height14mm |
| 00822409071135 | TibTrialSpacer Med Height12mm |
| 00822409071128 | TibTrialSpacer Med Height10mm |
| 00822409071111 | TibTrialSpacerSmall Height30mm |
| 00822409071104 | TibTrialSpacerSmall Height25mm |
| 00822409071098 | TibTrialSpacerSmall Height20mm |
| 00822409071081 | TibTrialSpacerSmall Height18mm |
| 00822409071074 | TibTrialSpacerSmall Height16mm |
| 00822409071067 | TibTrialSpacerSmall Height14mm |
| 00822409071050 | TibTrialSpacerSmall Height12mm |
| 00822409071043 | TibTrialSpacerSmall Height10mm |