|
Device |
spinous process plate |
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 the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use. |
Product Code | PEK |
Regulation Number |
888.3050
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
AURORA SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AURORA SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
DIO MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIO MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FLOSPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GLOBUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JG SPINE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALITEC DIRECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LDR SPINE, USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LESPINE INNOVATIONS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIFE SPINE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL DESIGNS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NUVASIVE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUVASIVE, INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PARADIGM SPINE GMBH |
|
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
|
SEASPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRUM SPINE IP HOLDINGS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL ELEMENTS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL SIMPLICITY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINAL SIMPLICITY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SPINAL SIMPLICITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEART |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPINEOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER SPINE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U & I CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZEL SPINE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
X-SPINE SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZAVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
XTANT Medical |
II |
Jan-28-2022 |
|
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|
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