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510(k) Data Aggregation
K Number
K151818Device Name
SImmetry Sacroiliac Joint Fusion System
Manufacturer
Zyga Technology, Inc.
Date Cleared
2015-08-05
(30 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry® Sacroiliac Joint Fusion is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged partially threaded or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm-14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm-110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm-14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
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K Number
K141549Device Name
SImmetry Sacroiliac Joint Fusion System
Manufacturer
Zyga Technology, Inc.
Date Cleared
2015-01-15
(218 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of sterile packaged lag or fully threaded, self-tapping cannulated titanium implants designed to transfix the sacrum and ilium, providing stability for bony fusion. The surgical implants are available in various sizes to accommodate patient anatomy. Implants have major diameters ranging from 6.5mm - 14.5mm, in 2mm increments. Lengths in 5mm increments range from 30mm- 110mm for fully threaded implants and 50mm to 110mm for partially threaded implants. All partially threaded implants and 6.5mm diameter fully threaded implants have a pre-assembled washer. Individually sterile packaged washers are available for fully threaded implants having diameters ranging from 8.5mm - 14.5mm. All devices are manufactured from Titanium Alloy (Ti-6Al-4V ELI).
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K Number
K130092Device Name
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Manufacturer
Zyga Technology, Inc.
Date Cleared
2013-02-27
(43 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry® Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac ioint disruptions and degenerative sacroiliitis.
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws.
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K Number
K111801Device Name
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
Manufacturer
Zyga Technology, Inc.
Date Cleared
2011-07-21
(24 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry™ Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Device Description
The SImmetry™ Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for use with the 6.5mm diameter screws.
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K Number
K110512Device Name
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Manufacturer
Zyga Technology, Inc.
Date Cleared
2011-03-23
(28 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
Device Description
The SImmetryTM Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm; titanium washers are available for the 6.5mm diameter screws. The revised surgical technique manual for the new modified version of the SImmetry™ Sacroiliac Joint Fusion System contain instructions for adding autologous graft material to the sacroiliac joint to help ensure fusion.
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K Number
K102907Device Name
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
Manufacturer
Zyga Technology, Inc.
Date Cleared
2010-12-14
(74 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Zyga Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SImmetry™ Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.
Device Description
The SImmetry Sacroiliac Joint Fusion System consists of cannulated screws available in titanium having diameters ranging from 6.5mm-12.5mm; and lengths of 30mm-70mm.
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