SURFIX PTOGND
GUDID M248PTOGND1
The SURFIX Knee Osteotomy System consists of different stainless steel plates for the proximal tibia and the distal femur with a locking system between the threaded sockets of the plates and the lock screws. Their fixation is provided by titanium alloy screws and lock screws available in two versions : cancellous bone screws diameter 6.5 mm and cortical bone screws diameter 4.5 mm. The system fixation creates a single implant/screw unit fixed into the bone thanks to the lock screw.
NEWDEAL
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | M248PTOGND1 |
| NIH Device Record Key | b317aa71-e48b-4105-9b0f-6c8324399077 |
| Commercial Distribution Discontinuation | 2027-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SURFIX |
| Version Model Number | PTOGND |
| Catalog Number | PTOGND |
| Company DUNS | 536935331 |
| Company Name | NEWDEAL |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
| Special Storage Condition, Specify | Between 0 and 0 *Must be stored in a dry, cool place away from dust and UV radiation |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780044475 [Primary] |
| HIBCC | M248PTOGND1 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041601
FDA Product Code
| HRS | PLATE, 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 | 5 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2017-10-09 |
On-Brand Devices [SURFIX]
| 10381780057543 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| M248SP100ND1 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051350 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051343 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051336 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051329 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051312 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051305 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051299 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051282 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051275 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051268 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051251 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| M248SP040ND1 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051237 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| M248SP030ND1 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051213 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| M248SP020ND1 | SURFIX Titanium cancellous bone screws and lock screws are available in different lengths from 2 |
| 10381780051190 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051183 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051176 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051169 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| M248CC045ND1 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051145 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051138 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051121 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051114 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051107 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051091 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051084 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051077 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051060 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| M248CC018ND1 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051046 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| 10381780051039 | SURFIX Titanium cortical bone screws and lock screws are available in different lengths from 14 |
| M248286334SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049913 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| M248286332SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049890 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| 10381780049883 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049876 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| M248286328SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049852 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| M248286326SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049838 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| M248286324SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049814 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| M248286322SND1 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
| 10381780049791 | Stainless steel Newdeal non sterile locking system fixation consists of screws and washers. This |
| 10381780049784 | Stainless steel Newdeal sterile locking system fixation consists of screws and washers. This sys |
Trademark Results [SURFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SURFIX 97788707 not registered Live/Pending |
Surfix Incorporated 2023-02-09 |
 SURFIX 87428160 5339969 Live/Registered |
PENETRON INTERNATIONAL LTD. 2017-04-27 |
 SURFIX 79097131 4120156 Live/Registered |
TTS Tooltechnic Systems AG & Co. KG 2010-12-30 |
 SURFIX 79006527 3324725 Live/Registered |
NEWDEAL 2004-06-07 |
 SURFIX 73325308 1223054 Live/Registered |
Helena Chemical Company 1981-08-26 |
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