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510(k) Data Aggregation
K Number
K221047Device Name
SILO TFX MIS Sacroiliac Joint Fixation System
Manufacturer
Aurora Spine, Inc.
Date Cleared
2022-10-03
(178 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Aurora Spine, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The Aurora Spine SILO TFX MIS Sacroiliac Joint Fixation System includes the SILO TFX Cone, SILO TFX Screw, and the SILO TFX Locking Screw and associated manual surgical instruments. The SILO TFX Cone is comprised of titanium alloy and incorporates a hollow conical shaped barrel with two openings for bone screws for additional anchoring. During the procedure, the implant is inserted in line with the SI Joint via a posterior surgical approach, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery.
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K Number
K221399Device Name
ZIP MIS Interspinous Fusion System
Manufacturer
Aurora Spine, Inc.
Date Cleared
2022-07-08
(56 days)
Product Code
PEK
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
Aurora Spine, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the 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), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
Device Description
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIPTM MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or sacral spine.
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K Number
K210521Device Name
DEXA-C Cervical Interbody System
Manufacturer
Aurora Spine, Inc.
Date Cleared
2021-08-02
(160 days)
Product Code
ODP
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Aurora Spine, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEXA-C Cervical Interbody System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1. DDD is defined as discogenic pain with the degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograff and/or allogenic bone graft composed of cancellous, cortical, and/or cortico-cancellous bone to facilitate fusion and is to be implanted via an open, anterior approach.
Device Description
The DEXA-C Cervical Interbody System is a porous 3D-printed intervertebral body fusion device that incorporates low-, mid-, or high-density lattice pattern options. The profile of the device is rectangular with a hollow core for bone graft to promote bone integration and fusion between the endplates. The device is available in various footbrints and heights to accommodate variability among patients and is manufactured from titanium alloy per ASTM F3001.
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K Number
K210325Device Name
APOLLO Anterior Cervical Plate (ACP) System
Manufacturer
Aurora Spine, Inc.
Date Cleared
2021-03-23
(47 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Aurora Spine, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APOLLO™ Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
· Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (including fractures or dislocations),
- · Tumors,
- · Deformity (defined as kyphosis, lordosis, or scoliosis),
- · Pseudarthrosis,
- · Failed previous fusion,
- · Spinal stenosis
Device Description
The APOLLO™ Anterior Cervical Plate (ACP) System is comprised of cervical plates and bone screws constructed of titanium alloy as described by ASTM F136. Plates are available in multiple levels and lengths, and screws are available in multiple diameters, lengths, and tip configurations to accommodate variations in patient anatomy. The Integrated screw locking mechanism is used to block the screw heads after the device construct has been attached to the anterior cervical spine.
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K Number
K141317Device Name
ZIP MIS INTERSPINOUS FUSION SYSTEM
Manufacturer
AURORA SPINE, INC.
Date Cleared
2014-11-17
(181 days)
Product Code
PEK
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
AURORA SPINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the 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), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
Device Description
The Aurora Spine ZIPIM MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.
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K Number
K140715Device Name
ZIP MIS INTERSPINOUS FUSION SYSTEM
Manufacturer
AURORA SPINE, INC.
Date Cleared
2014-04-17
(27 days)
Product Code
PEK
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
AURORA SPINE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the 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), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
Device Description
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior noncervical spine at the spinous processes. The implants have superior and inferior surfaces and a central chamber for receiving bone graft. The devices are available in a variety of cylinders to accommodate variations in pathology and patient anatomy. The Aurora Spine ZIP™ MIS Interspinous Fusion System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine.
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