TOMOFIX 440834
GUDID H6794408340
TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE-4 HOLES
Synthes GmbH
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | H6794408340 |
| NIH Device Record Key | f3f99c2e-a94a-4d8a-84fa-d8dc2d9bdce7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TOMOFIX |
| Version Model Number | 440.834 |
| Catalog Number | 440834 |
| Company DUNS | 486711679 |
| Company Name | Synthes GmbH |
| 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 | false |
| 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 | 10886982220691 [Primary] |
| HIBCC | H6794408340 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K023941
FDA Product Code
| HRS | PLATE, FIXATION, BONE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
[H6794408340]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-05-02 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [TOMOFIX]
| H679031200690 | TOMOFIX GUIDING BLOCK FOR MEDIAL DISTAL FEMUR PLATE-LT |
| H679031200680 | TOMOFIX GUIDING BLOCK FOR MEDIAL DISTAL FEMUR PLATE-RT |
| 07611819256156 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL DISTAL FEMUR-LEFT |
| 07611819256149 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL DISTAL FEMUR-RIGHT |
| 07611819256132 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL HIGH TIBIA-LEFT |
| 07611819256125 | TOMOFIX(TM) GUIDING BLOCK FOR LATERAL HIGH TIBIA-RIGHT |
| 07611819256118 | TOMOFIX(TM) GUIDING BLOCK FOR MEDIAL HIGH TIBIA |
| 07611819941885 | TOMOFIX GUIDING BLOCK F/MEDIAL HIGH TIBIA PLATE-SMALL |
| H67904120551S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/LEFT-STERILE |
| H679041205510 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/LEFT |
| H67904120550S0 | TI TOMOFIX MEDIAL DISTAL FEMUR PL/4 HOLES/RIGHT-STERILE |
| H679041205500 | TI TOMOFIX MEDIAL DISTAL FEMUR PLATE - 4 HOLES/RIGHT |
| H6796712980 | SYNCASE FOR TOMOFIX(TM) SCREW SET |
| H6796712940 | SYNCASE FOR TOMOFIX(TM) INSTRUMENT SET |
| H679601200500 | TOMOFIX INSTRUMENT AND TI IMPLANT SET GRAPHIC CASE |
| H6794408740 | TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/LEFT |
| H6794408640 | TI TOMOFIX(TM) LATERAL DISTAL FEMUR PLATE-4 HOLES/RIGHT |
| H6794408530 | TI TOMOFIX(TM) LATERAL HIGH TIBIA PLATE-3 HOLES/LEFT |
| H6794408430 | TI TOMOFIX(TM) LATERAL HIGH TIBIA PLATE-3 HOLES/RIGHT |
| H6794408340 | TI TOMOFIX(TM) MEDIAL HIGH TIBIA PLATE-4 HOLES |
| H6794408310 | TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL |
| 07611819275737 | TOMOFIX OSTEOTOMY CHISEL 25MM WIDTH |
| 07611819275720 | TOMOFIX OSTEOTOMY CHISEL 20MM WIDTH |
| 07611819275713 | TOMOFIX OSTEOTOMY CHISEL 15MM WIDTH |
| 07611819275706 | TOMOFIX OSTEOTOMY CHISEL 10MM WIDTH |
| 07611819284951 | TOMOFIX(TM) OSTEOTOMY GAP MEASURING DEVICE |
| 07611819278721 | TOMOFIX(TM) BONE SPREADER |
Trademark Results [TOMOFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TOMOFIX 76467177 2981413 Live/Registered |
DEPUY SYNTHES, INC. 2002-11-05 |
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