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510(k) Data Aggregation
K Number
K232878Device Name
TransLoc 3D
Manufacturer
Foundation Fusion Solutions, LLC (dba CornerLoc)
Date Cleared
2023-10-17
(29 days)
Product Code
OUR, CLA, HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Foundation Fusion Solutions, LLC (dba CornerLoc)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TransLoc 3D Screw is intended for sacroiliac joint fusion for conditions including:
· Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The TransLoc 3D Posterior Implant is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.
Device Description
TransLoc 3D implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as a Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone and may be used in the same procedure with CornerLoc bone graft. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint. All implants are provided sterile packaged for single use. Non-sterile instruments are available to assist with the surgical procedure and must be sterilized prior to use.
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K Number
K211496Device Name
TransLoc 3D
Manufacturer
Foundation Fusion Solutions, LLC (dba CornerLoc)
Date Cleared
2022-07-27
(440 days)
Product Code
OUR, CLA
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Foundation Fusion Solutions, LLC (dba CornerLoc)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TransLoc 3D is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. When the TransLoc 3D Posterior Implanted, it must be used with a TransLoc 3D Screw implanted across the same sacroiliac joint.
Device Description
The TransLoc 3D System implants are intended to transfix the sacroiliac (SI) joint for fusion procedures. These titanium 3D-printed devices are available in a range of lengths and include a threaded Screw version, as well as Posterior Implant version that incorporates circumferential teeth and a porous lattice pattern. The TransLoc 3D Screw may be implanted alone. The TransLoc 3D Posterior Implant is intended only for use along with a TransLoc 3D Screw implanted in the same sacroiliac joint.
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