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510(k) Data Aggregation
K Number
K162003Device Name
IMSE Cervical Cage
Date Cleared
2016-12-21
(154 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
The **Institute of Musculoskeletal Science **& Education
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When used as a cervical intervertebral fusion device, the IMSE Cervical Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior screw systems) cleared for use in the cervical spine.
Device Description
The IMSE Cervical Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of autograft inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The IMSE Cervical Cage of intervertebral body fusion devices are made from the PEEK (Solvay Zeniva ZA-500) radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.
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K Number
K130506Device Name
IMSE P-TLIF
Manufacturer
Date Cleared
2013-05-13
(75 days)
Product Code
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
**INSTITUTE OF MUSCULOSKELETAL SCIENCE **& EDUCATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IMSE P-TLIF is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). IMSEP-TLIF is to be used with autologous bone graft and implanted via an open transforaminal or posterior approach. IMSEP-TLIF implants are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Device Description
Institute of Musculoskeletal Science and Education, P-TLIF is a device for interbody fusion of the anterior column of the spine. These cages are hollow so that bone can grow through the device, fusing the adjacent bony surfaces. IMSE, P-TLIF is a hollow device with texture on two opposing convex sides, and is offered in various lengths, widths, heights and shapes. Institute of Musculoskeletal Science and Education designed the IMSE, P-TLIF to be placed through a transforaminal or posterior approach and to address vertebrae in the lumbosacral region of the spine.
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