DEVICE: ATHLET (04047844002353)
Device Identifier (DI) Information
ATHLET
Main body 4
In Commercial Distribution
AT0412
SIGNUS Medizintechnik GmbH
Main body 4
In Commercial Distribution
AT0412
SIGNUS Medizintechnik GmbH
The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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34170 | Vertebral body prosthesis |
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
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FDA Product Code
[?]Product Code | Product Code Name |
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MQP | Spinal Vertebral Body Replacement Device |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 12x14x15mm |
Device Record Status
83b4f6b3-81cf-4aba-8a97-0422cdc60570
February 24, 2020
5
September 24, 2015
February 24, 2020
5
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49602391660
info@signus.com
info@signus.com