Bendini

Basic Information

• Brand Name: Bendini
• Primary DI: 00887517246332
• Version / Model: 1592700
• Company Name: Nuvasive, Inc.
• Labeler DUNS: 053950783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9ccd3993-c59f-461f-9bd3-4f6ef62f76c3

Device Description

Bendini Rod Bender, Spinal

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
OLO	Orthopedic stereotaxic instrument	Neurology	882.4560	2
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
IKN	Electromyograph, diagnostic	Physical Medicine	890.1375	2
PDQ	Neurosurgical nerve locator	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60742	Electric orthopaedic bender	A mains electricity (AC-powered) surgical instrument, which may include a rechargeable battery, designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00887517246332	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141968	000