AccessGUDID - DEVICE: CAVUX™ Cervical Cage SB (00852776006423)

GUDID

Device Identifier (DI) Information

Brand Name: CAVUX™ Cervical Cage SB
Version or Model: PD-31-202
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Providence Medical Technology, Inc.

Primary DI Number: 00852776006423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969820245 *Terms of Use

Device Description: CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.

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?
58109	Implantable cervical facet joint distractor	A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122801	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
No Device Sizes

Device Record Status

Public Device Record Key: a41950ab-c072-443d-8f67-71fc66685330
Public Version Date: July 10, 2025
Public Version Number: 4
DI Record Publish Date: July 23, 2019