| Primary Device ID | 00814703017278 |
| NIH Device Record Key | e4aa9d18-dd8a-4ed6-9615-deb0a9f04d73 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Platform Hooded Acetabular Insert with E-Link |
| Version Model Number | 3512.48.032 |
| Company DUNS | 078416717 |
| Company Name | TOTAL JOINT ORTHOPEDICS, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com | |
| Phone | +1(801)486-6070 |
| udi@tjoinc.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814703017278 [Primary] |
| LZO | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
[00814703017278]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-06 |
| Device Publish Date | 2022-09-28 |
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| 00814703017353 | Hooded Acetabular Insert with E-Link, 36mm head, size 62mm |
| 00814703017346 | Hooded Acetabular Insert with E-Link, 36mm head, size 60mm |
| 00814703017339 | Hooded Acetabular Insert with E-Link, 36mm head, size 58mm |
| 00814703017322 | Hooded Acetabular Insert with E-Link, 36mm head, size 56mm |
| 00814703017315 | Hooded Acetabular Insert with E-Link, 36mm head, size 54mm |
| 00814703017308 | Hooded Acetabular Insert with E-Link, 36mm head, size 52mm |
| 00814703017292 | Hooded Acetabular Insert with E-Link, 36mm head, size 50mm |
| 00814703017285 | Hooded Acetabular Insert with E-Link, 32mm head, size 50mm |
| 00814703017278 | Hooded Acetabular Insert with E-Link, 32mm head, size 48mm |
| 00814703017261 | Hooded Acetabular Insert with E-Link, 32mm head, size 46mm |
| 00814703017254 | Hooded Acetabular Insert with E-Link, 28mm head, size 46mm |
| 00814703017247 | Hooded Acetabular Insert with E-Link, 28mm head, size 44mm |