AccessGUDID - DEVICE: TETRIS II 8° (04047844010730)

GUDID

Device Identifier (DI) Information

Brand Name: TETRIS II 8°
Version or Model: Lumbar cage, angled
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T2K8091124
Company Name: SIGNUS Medizintechnik GmbH

Primary DI Number: 04047844010730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344203948 *Terms of Use

Device Description: The basic shape of the TETRIS 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 avaiable in a variety of sizes and angulations thereby enabling the surgeon to choose the size best united to the individual pathology and anatomical condition.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polymeric spinal fusion cage, sterile	A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

GMDN Preferred Term Name

GMDN Definition

Polymeric spinal fusion cage, sterile

A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

FDA Product Code

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Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar
MQP	Spinal Vertebral Body Replacement Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122317	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 35 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 9x11x24mm,8°

Device Record Status

Public Device Record Key: 08c6de46-4ff2-4a95-becd-7470f99745b6
Public Version Date: August 22, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2015