DEVICE: ASCOT (04047844026243)
Device Identifier (DI) Information
ASCOT
Variable angle screw, self tapping
In Commercial Distribution
HV-4312
SIGNUS Medizintechnik GmbH
Variable angle screw, self tapping
In Commercial Distribution
HV-4312
SIGNUS Medizintechnik GmbH
ASCOT is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc desease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvertures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Spinal fixation plate, non-bioabsorbable | A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K132310 | 000 |
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: Ø4,3x12mm |
Device Record Status
177018c8-39af-4a7e-9d27-8c9c75661ecf
August 21, 2018
4
September 24, 2015
August 21, 2018
4
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49602391660
info@signus.com
info@signus.com