Spinal Vertebral Body Replacement Device

Device Code: 4626

Product Code(s): MQP

Device Type ID	4626
Device Name	Spinal Vertebral Body Replacement Device
Regulation Description	Spinal Intervertebral Body Fixation Orthosis.
Regulation Medical Specialty	Orthopedic
Review Panel	Orthopedic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Anterior Spine Devices Branch (ASDB)
Submission Type	510(k)
CFR Regulation Number	888.3060 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	MQP
GMP Exempt	No
Summary MR	Eligible
Implanted Device	Yes
Life Support Device	No
Third Party Review	Not Third Party Eligible

Device Type ID	4626
Device	Spinal Vertebral Body Replacement Device
Product Code	MQP
FDA Device Classification	Class 2 Medical Device
Regulation Description	Spinal Intervertebral Body Fixation Orthosis.
CFR Regulation Number	888.3060 [🔎]

Premarket Reviews
Manufacturer	Decision
AESCULAP IMPLANT SYSTEM, INC.
	SUBSTANTIALLY EQUIVALENT	2
AMENDIA, INC.
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE
	SUBSTANTIALLY EQUIVALENT	1
CAMBER SPINE/MEDICAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	1
CHOICE SPINE
	SUBSTANTIALLY EQUIVALENT	2
GLOBUS
	SUBSTANTIALLY EQUIVALENT	2
K2M
	SUBSTANTIALLY EQUIVALENT	2
K2M, INC.
	SUBSTANTIALLY EQUIVALENT	1
LDR SPINE USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDOS INTERNATIONAL SARL
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC SOFAMOR DANEK
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
NUVASIVE, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
OXFORD PERFORMANCE MATERIALS
	SUBSTANTIALLY EQUIVALENT	1
SIGNUS MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SPINE WAVE, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULRICH MEDICAL USA
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	155
Break	78
Migration Or Expulsion Of Device	64
Unintended Movement	23
No Apparent Adverse Event	21
Device Operates Differently Than Expected	19
Fracture	17
Device Dislodged Or Dislocated	13
Detachment Of Device Or Device Component	12
Mechanical Problem	11
Device Slipped	8
Malposition Of Device	7
Migration	7
Collapse	6
Spacer	5
Material Fragmentation	5
Appropriate Term/Code Not Available	5
Screw	5
Use Of Device Problem	4
Material Deformation	4
Loose Or Intermittent Connection	4
Device Markings / Labelling Problem	3
Inadequacy Of Device Shape And/or Size	3
Fitting Problem	2
Detachment Of Device Component	2
Positioning Problem	2
Crack	2
Disassembly	2
Material Integrity Problem	2
Unstable	1
Improper Or Incorrect Procedure Or Method	1
Inflation Problem	1
Patient-Device Incompatibility	1
Device Operational Issue	1
Device Difficult To Setup Or Prepare	1
Loss Of Or Failure To Bond	1
Component Missing	1
Structural Problem	1
Connecting Rod	1
Device Expiration Issue	1
Fluid Leak	1
Split	1
Defective Device	1
Device Or Device Fragments Location Unknown	1
Difficult To Position	1
Naturally Worn	1
Packaging Problem	1
Torn Material	1
Insufficient Information	1
Computer Software Problem	1
Disconnection	1
Difficult To Insert	1
Peeled / Delaminated	1
Device-Device Incompatibility	1
Unsealed Device Packaging	1
Mechanical Jam	1
Plate	1
Total Device Problems	519

TPLC Last Update: 2019-04-02 20:53:00