DIPLOMAT MIS AB0655-00050

GUDID 04047844031735

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 ID04047844031735
NIH Device Record Keyf85a7c10-5a3b-412d-b91b-8d1a9749107f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIPLOMAT MIS
Version Model NumberRod, straight
Catalog NumberAB0655-00050
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

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104047844031735 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

[04047844031735]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-10
Device Publish Date2018-09-10

On-Brand Devices [DIPLOMAT MIS]

04047844036402The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844036396The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031896The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031889The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031872The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031865The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031858The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031841The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031834The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031827The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031810The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031803The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031797The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031780The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031773The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031766The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031759The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031742The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031735The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031728The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031711The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031704The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844031698The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025369The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025352The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025345The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025338The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025321The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025314The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025307The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025291The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025284The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025277The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025260The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025253The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025246The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025239The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025222The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025215The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025208The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025192The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025185The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025178The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025161The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025154The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844025147The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844034354The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844034330The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844034316The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
04047844034293The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or mo
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