DEVICE: Taurus Pedicle Screw System (M555507000002)

Device Identifier (DI) Information

Taurus Pedicle Screw System
A
Not in Commercial Distribution
50-7000-002
AMEDICA CORPORATION
M555507000002
HIBCC
September 15, 2023
1
028629553 *Terms of Use
Inserter, Set-Screw, Palm, T30
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
47807 Surgical implant/trial-implant/sizer holder, reusable
A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KWQ Appliance, Fixation, Spinal Intervertebral Body
KWP Appliance, Fixation, Spinal Interlaminal
MNI Orthosis, Spinal Pedicle Fixation
MNH Orthosis, Spondylolisthesis Spinal Fixation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f6bf025c-5228-4617-b2c9-46428320f6b1
November 20, 2024
6
December 29, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
801-839-3500
customerservice@amedica.com
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