INTRAFIX 254684
GUDID 10886705013654
FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm
DEPUY MITEK, LLC
Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)| Primary Device ID | 10886705013654 |
| NIH Device Record Key | 9b3fd3c2-48a6-4dee-a50c-a45417dc2c1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INTRAFIX |
| Version Model Number | 254684 |
| Catalog Number | 254684 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, LLC |
| 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 |
Customer Support Contacts
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705013654 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063577
FDA Product Code
| HWC | Screw, fixation, bone |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-11-02 |
| Device Publish Date | 2015-09-01 |
On-Brand Devices [INTRAFIX]
| 10886705013524 | Femoral INTRAFIX Sheath Inserter 9mm - 10mm |
| 10886705013517 | Femoral INTRAFIX Sheath Inserter 8mm - 8.5mm |
| 10886705013500 | Femoral INTRAFIX Sheath Inserter 7mm - 7.5mm |
| 10886705013494 | Femoral INTRAFIX Sheath Trial 9mm - 10mm |
| 10886705013487 | Femoral INTRAFIX Sheath Trial 8mm - 8.5mm |
| 10886705013470 | Femoral INTRAFIX Sheath Trial 7mm - 7.5mm |
| 10886705013166 | INTRAFIX Family Tibial Sheath Inserter with Fixed Handle |
| 10886705013159 | INTRAFIX Tibial Sheath Trial with Fixed Handle |
| 10886705013142 | INTRAFIX Tibial Sheath Inserter with Fixed Handle |
| 10886705005246 | Femoral INTRAFIX Sterilization Tray |
| 10886705013661 | FEMORAL INTRAFIX, STANDARD Includes (1) 9mm Sheath and (1) 9mm Screw 9mm-10mm x 23mm |
| 10886705013654 | FEMORAL INTRAFIX, HARD Includes (1) 9mm Sheath and (1) 8mm Screw 9mm-10mm x 23mm |
| 10886705013647 | FEMORAL INTRAFIX, STANDARD Includes (1) 8mm Sheath and (1) 8mm Screw 8mm-8.5mm x 23mm |
| 10886705013630 | FEMORAL INTRAFIX, HARD Includes (1) 8mm Sheath and (1) 7mm Screw 8mm-8.5mm x 23mm |
| 10886705013623 | FEMORAL INTRAFIX, STANDARD Includes (1) 7mm Sheath and (1) 7mm Screw 7mm-7.5mm x 23mm |
| 10886705013616 | FEMORAL INTRAFIX, HARD Includes (1) 7mm Sheath and (1) 6mm Screw 7mm-7.5mm x 23mm |
Trademark Results [INTRAFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INTRAFIX 76629628 3052822 Live/Registered |
JOHNSON & JOHNSON 2005-01-27 |
 INTRAFIX 74062180 not registered Dead/Abandoned |
Orthofix S.R.L. 1990-05-24 |
 INTRAFIX 72293928 0877779 Dead/Expired |
INTRAVEND A.G. 1968-03-22 |
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