Hintermann Series H2
GUDID 00841731138316
H2 Vit E Poly Assembly, Sz0, Right, 9mm, Neutral
VILEX LLC
Ankle prosthesis bearing| Primary Device ID | 00841731138316 |
| NIH Device Record Key | cb654b50-2496-48df-ac2c-3874a1e8109d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hintermann Series H2 |
| Version Model Number | HT-37009 |
| Company DUNS | 117502293 |
| Company Name | VILEX LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
Customer Support Contacts
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com | |
| Phone | +1(800)521-5002 |
| info@vilex.com |
Device Dimensions
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841731138316 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240475
FDA Product Code
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
[00841731138316]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-15 |
| Device Publish Date | 2025-09-05 |
On-Brand Devices [Hintermann Series H2 ]
| 00841731142320 | Hintermann Series H2 Tibial Slide, Size 6 |
| 00841731142313 | Hintermann Series H2 Tibial Slide, Size 5 |
| 00841731142306 | Hintermann Series H2 Tibial Slide, Size 4 |
| 00841731142290 | Hintermann Series H2 Tibial Slide, Size 3 |
| 00841731142283 | Hintermann Series H2 Tibial Slide, Size 1/2 |
| 00841731142276 | Hintermann Series H2 Tibia Implant, Sz6 Left, 12mm |
| 00841731142269 | Hintermann Series H2 Tibia Implant, Sz6 Left, 9.5mm |
| 00841731142252 | Hintermann Series H2 Tibia Implant, Sz6 Left, 7mm |
| 00841731142245 | Hintermann Series H2 Tibia Implant, Sz5 Left, 12mm |
| 00841731142238 | Hintermann Series H2 Tibia Implant, Sz5 Left, 9.5mm |
| 00841731142221 | Hintermann Series H2 Tibia Implant, Sz5 Left, 7mm |
| 00841731142214 | Hintermann Series H2 Tibia Implant, Sz4 Left, 12mm |
| 00841731142207 | Hintermann Series H2 Tibia Implant, Sz4 Left, 9.5mm |
| 00841731142191 | Hintermann Series H2 Tibia Implant, Sz4 Left, 7mm |
| 00841731142184 | Hintermann Series H2 Tibia Implant, Sz3 Left, 12mm |
| 00841731142177 | Hintermann Series H2 Tibia Implant, Sz3 Left, 9.5mm |
| 00841731142160 | Hintermann Series H2 Tibia Implant, Sz3 Left, 7mm |
| 00841731142153 | Hintermann Series H2 Tibia Implant, Sz2 Left, 12mm |
| 00841731142146 | Hintermann Series H2 Tibia Implant, Sz2 Left, 9.5mm |
| 00841731142139 | Hintermann Series H2 Tibia Implant, Sz2 Left, 7mm |
| 00841731142122 | Hintermann Series H2 Tibia Implant, Sz1 Left, 12mm |
| 00841731142115 | Hintermann Series H2 Tibia Implant, Sz1 Left, 9.5mm |
| 00841731142108 | Hintermann Series H2 Tibia Implant, Sz1 Left, 7mm |
| 00841731142092 | Hintermann Series H2 Tibia Implant, Sz6 Right, 12mm |
| 00841731142085 | Hintermann Series H2 Tibia Implant, Sz6 Right, 9.5mm |
| 00841731142078 | Hintermann Series H2 Tibia Implant, Sz6 Right, 7mm |
| 00841731142061 | Hintermann Series H2 Tibia Implant, Sz5 Right, 12mm |
| 00841731142054 | Hintermann Series H2 Tibia Implant, Sz5 Right, 9.5mm |
| 00841731142047 | Hintermann Series H2 Tibia Implant, Sz5 Right, 7mm |
| 00841731142030 | Hintermann Series H2 Tibia Implant, Sz4 Right, 12mm |
| 00841731142023 | Hintermann Series H2 Tibia Implant, Sz4 Right, 9.5mm |
| 00841731142016 | Hintermann Series H2 Tibia Implant, Sz4 Right, 7mm |
| 00841731142009 | Hintermann Series H2 Tibia Implant, Sz3 Right, 12mm |
| 00841731141996 | Hintermann Series H2 Tibia Implant, Sz3 Right, 9.5mm |
| 00841731141989 | Hintermann Series H2 Tibia Implant, Sz3 Right, 7mm |
| 00841731141972 | Hintermann Series H2 Tibia Implant, Sz2 Right, 12mm |
| 00841731141965 | Hintermann Series H2 Tibia Implant, Sz2 Right, 9.5mm |
| 00841731141958 | Hintermann Series H2 Tibia Implant, Sz2 Right, 7mm |
| 00841731141941 | Hintermann Series H2 Tibia Implant, Sz1 Right, 12mm |
| 00841731138477 | H2 Vit E Poly Assembly, Sz 0, Left, 9mm, Anterior |
| 00841731138460 | H2 Vit E Poly Assembly, Sz 0, Left, 7mm, Anterior |
| 00841731138453 | H2 Vit E Poly Assembly, Sz 0, Left, 6mm, Anterior |
| 00841731138446 | H2 Vit E Poly Assembly, Sz 0, Left, 5mm, Anterior |
| 00841731138439 | H2 Vit E Poly Assembly, Sz 0, Left, 9mm, Neutral |
| 00841731138422 | H2 Vit E Poly Assembly, Sz 0, Left, 7mm, Neutral |
| 00841731138415 | H2 Vit E Poly Assembly, Sz 0, Left, 6mm, Neutral |
| 00841731138408 | H2 Vit E Poly Assembly, Sz 0, Left, 5mm, Neutral |
| 00841731138354 | H2 Vit E Poly Assembly, Sz0, Right, 9mm, Anterior |
| 00841731138347 | H2 Vit E Poly Assembly, Sz0, Right, 7mm, Anterior |
| 00841731138330 | H2 Vit E Poly Assembly, Sz0, Right, 6mm, Anterior |
Trademark Results [Hintermann Series H2]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HINTERMANN SERIES H2 86848301 5453980 Live/Registered |
DT MEDTECH, LLC 2015-12-14 |
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