DIPLOMAT FT AB1310-75040

GUDID 04047844117606

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 Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	04047844117606
NIH Device Record Key	0388f926-3b50-4bcb-b75f-f434280d7b0c
Commercial Distribution Status	In Commercial Distribution
Brand Name	DIPLOMAT FT
Version Model Number	Pedicle screw, fenestrated, monoaxial
Catalog Number	AB1310-75040
Company DUNS	344203948
Company Name	SIGNUS Medizintechnik 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	true
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	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com
Phone	+49602391660
Email	info@signus.com

Device Dimensions

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Device Size Text, specify	0
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Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844117606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151704

FDA Product Code

NKB	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease