Definition: This Device Is A Posterior Spinal System That Contains Polymer And Metal Components. This Spinal System Is To Be Used With Bone Graft And Is An Adjunct To Fusion In The Treatment Of Acute And Chronic Instabilities Or Deformities Of The Thoracic, Lumb
| Device Type ID | 4647 |
| Device Name | Posterior Metal/polymer Spinal System, Fusion |
| 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 | NQP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4647 |
| Device | Posterior Metal/polymer Spinal System, Fusion |
| Product Code | NQP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thoracolumbosacral Pedicle Screw System. |
| CFR Regulation Number | 888.3070 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER SPINE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 24 |
Break | 14 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Fracture | 7 |
Malposition Of Device | 6 |
Migration Or Expulsion Of Device | 5 |
Appropriate Term/Code Not Available | 4 |
Cut In Material | 4 |
Device-Device Incompatibility | 2 |
Material Fragmentation | 2 |
Material Too Rigid Or Stiff | 1 |
Component Or Accessory Incompatibility | 1 |
Mechanical Jam | 1 |
Tape | 1 |
Partial Blockage | 1 |
Failure To Align | 1 |
Torn Material | 1 |
Device Slipped | 1 |
Microbial Contamination Of Device | 1 |
Noise, Audible | 1 |
Loose Or Intermittent Connection | 1 |
Screw | 1 |
Cord | 1 |
No Apparent Adverse Event | 1 |
Material Frayed | 1 |
Device Operates Differently Than Expected | 1 |
Device Inoperable | 1 |
Electronic Property Issue | 1 |
| Total Device Problems | 94 |