AccessGUDID - DEVICE: Taurus Pedicle Screw System (M555510000002)

GUDID

Device Identifier (DI) Information

Brand Name: Taurus Pedicle Screw System
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 51-0000-002
Company Name: AMEDICA CORPORATION

Primary DI Number: M555510000002
Issuing Agency: HIBCC
Commercial Distribution End Date: November 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 028629553 *Terms of Use

Device Description: Taurus Pedicle Screw System- Headbody, Assembly, Reduction

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bf22a6ea-cae7-478a-b5ea-b519c0bb8c90
Public Version Date: November 20, 2024
Public Version Number: 6
DI Record Publish Date: December 29, 2017