AccessGUDID - DEVICE: Tether™ (10889981035976)

GUDID

Device Identifier (DI) Information

Brand Name: Tether™
Version or Model: 03-12-4017
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 03-12-4017
Company Name: SEASPINE ORTHOPEDICS CORPORATION

Primary DI Number: 10889981035976
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Screw - Self-Tapping - Variable - 4.0x17mm

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:	No
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?
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K010466	000

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
Device Size Text, specify: 4.0x17mm

Device Record Status

Public Device Record Key: 0f246fd8-efb1-4e06-8bf2-a883b78ebf1c
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2015