MOBIS II 0° B20150929

GUDID 04047844015759

The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered leading face. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is avaible in a variety of sizes and two angulations thereby enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

SIGNUS Medizintechnik GmbH

Polymeric spinal interbody fusion cage
Primary Device ID04047844015759
NIH Device Record Key55fe241d-bc1c-4020-9929-bc7dcb2d40ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameMOBIS II 0°
Version Model NumberLumbar cage, straight
Catalog NumberB20150929
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 Datetrue
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

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
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
GS104047844015759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-10-11
Device Publish Date2015-09-24

On-Brand Devices [MOBIS II 0°]

04047844015957The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016046The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016039The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016022The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016015The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844016008The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015995The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015988The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015971The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015964The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015940The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015933The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015926The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore
04047844015919The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015780The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015773The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015766The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015759The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015742The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015735The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015728The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015711The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015704The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015698The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015681The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le
04047844015674The basic shape of the MOBIS II devices is a hollow structual frame having a rounded, tapered le

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.