| 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 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Atlas Spine, Inc. | II | May-06-2016 |
| 2 | Eden Spine Europe SA | II | May-12-2017 |
| 3 | Synthes USA (HQ), Inc. | II | Jun-26-2015 |
| 4 | Synthes, Inc. | II | Jun-02-2014 |