SImmetry Implant, 12.5mm x 45mm

Basic Information

• Brand Name: SImmetry Implant, 12.5mm x 45mm
• Primary DI: 04260636674938
• Version / Model: 10-P12545-01
• Company Name: Paradigm Spine GmbH
• Labeler DUNS: 537619731
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-25
• Public Version: 2
• Public Version Date: 2021-06-10
• Public Version Status: Update
• Public Device Record Key: db86993c-1974-4f2a-8283-6cf47715c093

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58088	Microbial water purification filter, non-sterilizable	A sterile device designed to remove bacteria and other suspended particles from flowing water by creating a mechanical barrier to elements larger than 0.2 micrometres. It typically consists of a plastic housing with a connector to the water source [e.g., a tap (faucet)] and a 0.2 micrometre filtering membrane [e.g., made of nylon, polyvinylidene fluoride (PVDF), or polyethersulfone (PES)]; a prefiltration of the water to remove larger particles is typically recommended. It is typically used for hygienic and surgical hand washing, wound irrigation, and/or rinsing of medical devices. This is a disposable, non-sterilizable device which may serve multiple patients before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260636674938	GS1

Premarket Submissions

Submission Number	Supplement Number
K151818	000