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Use the links below to download copies of the 510(K) Clearance Letters as required by Section 807 sub-section (C) for each of Custom Spine products.
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![]() ISSYS LP 510(K) Clearance Letter |
![]() Regent ACP 510(K) Clearance Letter |
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![]() Pathway ACIF 510(K) Clearance Letter |
![]() Pathway TLIF/PLIF 510(K) Clearance Letter |
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To request additional information about Custom Spine products, please contact Melanie Musick at mmusick@customspine.com or via phone at 404-695-4185.
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