MOBIS II 0° B2L0160929

GUDID 04047844016022

The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore titanium grid structure. Restoration of the intervertebral space can be achieved by the large selection of implants that, at the same time, offers a high degree of intraoperative flexibility. in addition to straight implants, the MOBIS II ST cage is alos aviable with a 5° lordoctic angle. Due to its design, the implant can be aligned with the anterior curvature of the intervertebral body and so is suited for unilateral, dorsal access (TLIF) in the L2 to S1 region of the spine.

SIGNUS Medizintechnik GmbH

Metallic spinal interbody fusion cage

• Primary Device ID: 04047844016022
• NIH Device Record Key: bc8e6e4c-c3d1-48d3-9868-4b9bf7a4968d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOBIS II 0°
• Version Model Number: Lumbar cage, straight
• Catalog Number: B2L0160929
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844016022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141405

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-24

On-Brand Devices [MOBIS II 0°]

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