AccessGUDID - DEVICE: ENDOSKELETON TA (M682210672090)

GUDID

Device Identifier (DI) Information

Brand Name: ENDOSKELETON TA
Version or Model: 2106-7209
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2106-7209
Company Name: TITAN SPINE, LLC

Primary DI Number: M682210672090
Issuing Agency: HIBCC
Commercial Distribution End Date: September 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 623316978 *Terms of Use

Device Description: 7 DEG LORDOTIC, RASP, LARGE, 9MM

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?
35559	Bone file/rasp, manual, reusable	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MAX	Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Lordotic Angle 7 Deg
Height: 9 Millimeter
Width: 36 Millimeter
Depth: 24 Millimeter
Angle: 7 degree
Device Size Text, specify: width(MLxAP), 36 x 24, mm

Device Record Status

Public Device Record Key: 5b9113c3-7576-4bd2-ac73-7a064700e943
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 17, 2016