DEVICE: AVS Anchor-L (07613252602101)
Device Identifier (DI) Information
AVS Anchor-L
48662204
In Commercial Distribution
48662204
Stryker Corporation
48662204
In Commercial Distribution
48662204
Stryker Corporation
VERTEBRAL SPACER
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]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, non-sterile | A non-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. This device must be sterilized prior to use. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OVD | Intervertebral fusion device with integrated fixation, lumbar |
MAX | Intervertebral fusion device with bone graft, lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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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Angle: 4.0 degree |
Length: 22.0 Millimeter |
Width: 30.0 Millimeter |
Height: 20.0 Millimeter |
Device Record Status
640c5df0-05d0-4cfc-92d9-b231decb822f
March 29, 2018
2
September 14, 2015
March 29, 2018
2
September 14, 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
[?]
No Customer Contact currently defined