DIPLOMAT FT AB1310-65065

GUDID 04047844117576

The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.

SIGNUS Medizintechnik GmbH

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID04047844117576
NIH Device Record Key87f914b2-aace-4672-b081-0115e86b25d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIPLOMAT FT
Version Model NumberPedicle screw, fenestrated, monoaxial
Catalog NumberAB1310-65065
Company DUNS344203948
Company NameSIGNUS Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com
Phone+49602391660
Emailinfo@signus.com

Device Dimensions

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Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844117576 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

[04047844117576]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-05
Device Publish Date2023-03-28

On-Brand Devices [DIPLOMAT FT]

04047844120170The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120163The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120156The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120149The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120132The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120125The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120118The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120101The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120095The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120088The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120071The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120064The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120057The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120040The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120033The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120026The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120019The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844120002The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119990The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119983The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119976The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119969The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119952The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119945The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119938The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119921The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119914The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119907The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119891The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119884The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119877The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119860The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119853The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119846The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119839The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119822The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119815The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119808The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119792The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119785The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119778The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119761The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119754The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119747The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119730The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119723The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119716The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119709The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119693The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844119686The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
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