Facet Screw System

Basic Information

• Brand Name: Facet Screw System
• Primary DI: 00815362023488
• Version / Model: 35-S4535-X
• Catalog Number: 35-S4535-X
• Company Name: PRECISION SPINE, INC.
• Labeler DUNS: 079398589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-01
• Public Version: 1
• Public Version Date: 2019-04-09
• Public Version Status: New
• Public Device Record Key: cf03d3c9-77d9-4463-97ee-ab3ab8d69362

Device Description

4.5 x 35mm Non-Cannulated Screw

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MRW	System, Facet Screw Spinal Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
63359	Trans-facet-screw internal spinal fixation system, non-sterile	A non-sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. This is a single-use device intended to be sterilized prior to use.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815362023488	GS1

Premarket Submissions

Submission Number	Supplement Number
K130863	000