Orthosis, Spondylolisthesis Spinal Fixation

Device Code: 4623

Product Code(s): MNH

Device Type ID	4623
Device Name	Orthosis, Spondylolisthesis Spinal Fixation
Regulation Description	Thoracolumbosacral Pedicle Screw System.
Regulation Medical Specialty	Orthopedic
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB)
Submission Type	510(k)
CFR Regulation Number	888.3070 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	MNH
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	4623
Device	Orthosis, Spondylolisthesis Spinal Fixation
Product Code	MNH
FDA Device Classification	Class 2 Medical Device
Regulation Description	Thoracolumbosacral Pedicle Screw System.
CFR Regulation Number	888.3070 [🔎]

Premarket Reviews
Manufacturer	Decision
CANWELL MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CAPTIVA SPINE
	SUBSTANTIALLY EQUIVALENT	2
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
CHIN BONE TECHNIQUE CORP
	SUBSTANTIALLY EQUIVALENT	1
HUNG CHUN BIO-S CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVASIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE SURGICAL DESIGNS
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KALITEC MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
L&K BIOMED CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICREA INTERNATIONAL S.A.
	SUBSTANTIALLY EQUIVALENT	1
NEXUS SPINE, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEXXT SPINE LLC
	SUBSTANTIALLY EQUIVALENT	1
RELIANCE MEDICAL SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPINEART
	SUBSTANTIALLY EQUIVALENT	2
SPINEFRONTIER INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEFRONTIER, INC.
	SUBSTANTIALLY EQUIVALENT	2
SPINEVISION
	SUBSTANTIALLY EQUIVALENT	1
SPINEVISION, S.A.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
VALOREM SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
ZAVATION, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	102
Break	84
Fracture	70
Mechanical Problem	68
Migration Or Expulsion Of Device	41
Material Integrity Problem	36
Material Deformation	32
Device Dislodged Or Dislocated	31
Screw	25
Detachment Of Device Or Device Component	20
Device Operates Differently Than Expected	17
Rod	15
Insufficient Information	12
Loose Or Intermittent Connection	11
No Apparent Adverse Event	10
Unintended Movement	9
Device-Device Incompatibility	9
Mechanical Jam	8
Detachment Of Device Component	6
Disassembly	6
Bent	6
Material Split, Cut Or Torn	5
Fitting Problem	5
Use Of Device Problem	4
Material Twisted / Bent	4
Device Inoperable	4
Material Separation	3
Connector	3
Device Slipped	3
Thread	2
Crack	2
Difficult To Insert	2
Malposition Of Device	2
Biocompatibility	2
Positioning Problem	2
Improper Or Incorrect Procedure Or Method	2
Cap	2
Heads	2
Misassembled	2
Connection Problem	1
Metal Shedding Debris	1
Appropriate Term/Code Not Available	1
Tip	1
Human-Device Interface Problem	1
Migration	1
Failure To Adhere Or Bond	1
Dull, Blunt	1
Component Falling	1
Disconnection	1
Difficult To Position	1
Torn Material	1
Incomplete Or Missing Packaging	1
Device Damaged By Another Device	1
Material Protrusion / Extrusion	1
Locking Mechanism	1
Device Handling Problem	1
Loosening Of Implant Not Related To Bone-Ingrowth	1
Material Fragmentation	1
Inadequacy Of Device Shape And/or Size	1
Sticking	1
Total Device Problems	690

TPLC Last Update: 2019-04-02 20:52:58