Accu Spina / Spina System Cervical

Basic Information

• Brand Name: Accu Spina / Spina System Cervical
• Primary DI: 00869444000218
• Version / Model: 21
• Company Name: NORTH AMERICAN MEDICAL CORPORATION
• Labeler DUNS: 031023091
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: df6ba08c-8bf6-4e9d-91fc-594ae3d9a749

Device Description

Physiotherapeutic treament device

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITH	Equipment, Traction, Powered	Physical Medicine	890.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45537	Static/intermittent powered traction system, non-mobile	An assembly of devices capable of applying continuous and various intermittent (regular, progressive/regressive, cycled) traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of an AC-powered motor with a control unit used to generate and regulate the mechanical forces, and a cord clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used primarily to widen intervertebral spaces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00869444000218	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033231	000

Device Sizes

Type	Value	Unit	Text
Length	128	Inch
Width	58	Inch
Height	88	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity