ZAVATION ROD BENDER

Basic Information

• Brand Name: ZAVATION ROD BENDER
• Primary DI: 00197157071417
• Version / Model: 989-1065-L
• Company Name: Zavation LLC
• Labeler DUNS: 069472800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-15
• Public Version: 2
• Public Version Date: 2025-11-20
• Public Version Status: Update
• Public Device Record Key: cb010029-3471-4b80-bf0d-4e8dd0e8bedd

Device Description

INSITU BENDER - LEFT 6.0 ROD

Device Characteristics

• Single Use: No
• 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: 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
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44795	Manual orthopaedic bender, reusable	A manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. It is typically in the form of pliers, a rod-like (e.g., pin) or bench-top device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00197157071417	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243908	000