DEVICE: Asfora Anterior Cervical Plate System (M364111106FD4740)
Device Identifier (DI) Information
Asfora Anterior Cervical Plate System
11-1106-FD4-74
In Commercial Distribution
MEDICAL DESIGNS LLC
11-1106-FD4-74
In Commercial Distribution
MEDICAL DESIGNS LLC
4 Level, 74mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (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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No |
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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K143688 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0df7686b-7ab0-4771-905c-f497d9782f21
July 06, 2018
3
September 27, 2016
July 06, 2018
3
September 27, 2016
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
[?]
605-275-1032
kspielman@medicaldesignsllc.com
kspielman@medicaldesignsllc.com