AccessGUDID - DEVICE: T2 STRATOSPHERE Expandable Corpectomy System (00643169709607)

GUDID

Device Identifier (DI) Information

Brand Name: T2 STRATOSPHERE Expandable Corpectomy System
Version or Model: 436120455
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169709607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: ENDCAP 436120455 EXTND 20X45MM 15 DEG ST

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?
34170	Vertebral body prosthesis	An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQP	Spinal vertebral body replacement device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183510	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20×45MM

Device Record Status

Public Device Record Key: fd6a34bf-80df-46c2-b69a-12dfd37262bb
Public Version Date: February 24, 2020
Public Version Number: 2
DI Record Publish Date: September 08, 2019