AccessGUDID - DEVICE: CROSS-FUSE™* II PEEK VBR/IBF SYSTEM (00846468007997)

GUDID

Device Identifier (DI) Information

Brand Name: CROSS-FUSE™* II PEEK VBR/IBF SYSTEM
Version or Model: 38-1850-11-6L
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468007997
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: Crossfuse II Imp, 18x50x11, 6degree lordosis

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?
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
ODP	Intervertebral fusion device with bone graft, cervical
MAX	Intervertebral fusion device with bone graft, lumbar
MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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: 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
No Device Sizes

Device Record Status

Public Device Record Key: 0a9acb97-1373-4608-b781-877482d58e9e
Public Version Date: December 05, 2024
Public Version Number: 6
DI Record Publish Date: December 21, 2015