Definition: A Posterior, Non-pedicle Supplemental Fixation Device Intended For Single Level Use In The Non-cervical Spine (T1-S1). It Is Intended For Single Level Plate Fixation/attachment To Spinous Process For The Purpose Of Achieving Supplemental Fusion In Th
| Device Type ID | 4680 |
| Device Name | Spinous Process Plate |
| Physical State | Plates With Teeth/spikes And Crossbar/tray/bumper That Connects And Locks Plates Together, Metallic, Metallic And Polymer Combination |
| Technical Method | Placed Between Two Spinous Processes To Immobilize The Segment, Provide Supplemental Stabilization, And To Facilitate Fusion At The Treated Level |
| Target Area | Non-cervical Spine (T1-S1) |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| 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 | 888.3050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4680 |
| Device | Spinous Process Plate |
| Product Code | PEK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| CFR Regulation Number | 888.3050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AURORA SPINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CELLUMED CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KALITEC MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LDR SPINE, USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUVASIVE, INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARADIGM SPINE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRECISION SPINE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
RELIANCE MEDICAL SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL SIMPLICITY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINAL SIMPLICITY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEART | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEOLOGY INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SPINEOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U & I CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZAVATION, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 2 |
| Total Device Problems | 2 |