ShurFit Lumbar Interbody

Basic Information

• Brand Name: ShurFit Lumbar Interbody
• Primary DI: 00840019947732
• Version / Model: 72-CPA-2414
• Catalog Number: 72-CPA-2414
• Company Name: PRECISION SPINE, INC.
• Labeler DUNS: 079398589
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-19
• Public Version: 1
• Public Version Date: 2022-10-27
• Public Version Status: New
• Public Device Record Key: 512a6b5b-ea54-4d07-8f19-5eac16f6f680

Device Description

24 x 14mm 0° Curved PEEK Interbody

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60676	JAK2 V617F gene mutation IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to detect or monitor the V617F mutation in the Janus kinase 2 (JAK2) gene in a clinical specimen. This mutation is associated with haematological abnormalities that may include essential thrombocythemia, polycythemia vera, primary myelofibrosis or leukaemia.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840019947732	GS1

Premarket Submissions

Submission Number	Supplement Number
K212075	000