AccessGUDID - DEVICE: Taurus Pedicle Screw System (M555510000000)

GUDID

Device Identifier (DI) Information

Brand Name: Taurus Pedicle Screw System
Version or Model: A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 51-0000-000
Company Name: AMEDICA CORPORATION

Primary DI Number: M555510000000
Issuing Agency: HIBCC
Commercial Distribution End Date: September 15, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 028629553 *Terms of Use

Device Description: Taurus Pedicle Screw System- Set Screw T30

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?
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	Appliance, Fixation, Spinal Interlaminal
MNH	Orthosis, Spondylolisthesis Spinal Fixation
KWQ	Appliance, Fixation, Spinal Intervertebral Body
MNI	Orthosis, Spinal Pedicle 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: cb2027e8-14fe-4b15-a01f-64f55dcb9ace
Public Version Date: July 14, 2025
Public Version Number: 7
DI Record Publish Date: December 29, 2017