AccessGUDID - DEVICE: CORUS PCSS Implant, 5mm (00852776006676)

GUDID

Device Identifier (DI) Information

Brand Name: CORUS PCSS Implant, 5mm
Version or Model: DX-50-404
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Providence Medical Technology, Inc.

Primary DI Number: 00852776006676
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 969820245 *Terms of Use

Device Description: CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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
No Product Codes

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: 030484e3-16a9-4e37-843d-1a29035af77c
Public Version Date: March 06, 2025
Public Version Number: 2
DI Record Publish Date: February 19, 2025