DEVICE: Taurus Pedicle Screw System (M555510000002)
Device Identifier (DI) Information
Taurus Pedicle Screw System
A
Not in Commercial Distribution
51-0000-002
AMEDICA CORPORATION
A
Not in Commercial Distribution
51-0000-002
AMEDICA CORPORATION
Taurus Pedicle Screw System- Headbody, Assembly, Reduction
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
66948 | Spinal bone screw head/rod adaptor |
A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
MNI | Orthosis, Spinal Pedicle Fixation |
KWP | Appliance, Fixation, Spinal Interlaminal |
MNH | Orthosis, Spondylolisthesis Spinal Fixation |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
bf22a6ea-cae7-478a-b5ea-b519c0bb8c90
November 20, 2024
6
December 29, 2017
November 20, 2024
6
December 29, 2017
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
[?]
801-839-3500
customerservice@amedica.com
customerservice@amedica.com