Cuff, Nerve

Device Code: 3733

Product Code(s): JXI

Device Classification Information

• Device Type ID: 3733
• Device Name: Cuff, Nerve
• Regulation Description: Nerve Cuff.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: 510(k)
• CFR Regulation Number: 882.5275 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: JXI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3733
• Device: Cuff, Nerve
• Product Code: JXI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nerve Cuff.
• CFR Regulation Number: 882.5275 [🔎]

Premarket Reviews
Manufacturer	Decision
AXOGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
COLLAGEN MATRIX, INC.
	SUBSTANTIALLY EQUIVALENT	2
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA
	SUBSTANTIALLY EQUIVALENT	2
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Appropriate Term/Code Not Available	2
Device Operates Differently Than Expected	2
Device Expiration Issue	2
Shelf Life Exceeded	2
Device Contamination With Chemical Or Other Material	1
Device Handling Problem	1
Patient Device Interaction Problem	1
Expiration Date Error	1
Device Appears To Trigger Rejection	1
Improper Or Incorrect Procedure Or Method	1
No Apparent Adverse Event	1
Total Device Problems	19

TPLC Last Update: 2019-04-02 20:35:40