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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K180891

EVOL Spinal Interbody System, EVOS Lumbar Interbody System · Cutting Edge Spine, LLC · decided 2018-05-04 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
EVOL® Lumbar Interbody SystemHLB04012Cutting Edge Spine, LLCMAX00841193120751
EVOL® Lumbar Interbody SystemHLB04009Cutting Edge Spine, LLCMAX00841193120744
EVOL® Lumbar Interbody SystemHLB04011Cutting Edge Spine, LLCMAX00841193120720
EVOL® Lumbar Interbody SystemHLB04017Cutting Edge Spine, LLCMAX00841193120805
EVOL® Lumbar Interbody SystemHLB04014Cutting Edge Spine, LLCMAX00841193120775
EVOL® Lumbar Interbody SystemHLB04016Cutting Edge Spine, LLCMAX00841193120799
EVOL® Lumbar Interbody SystemHLB04015Cutting Edge Spine, LLCMAX00841193120782
EVOL® Lumbar Interbody SystemHLB04013Cutting Edge Spine, LLCMAX00841193120768
EVOL® Lumbar Interbody SystemHLB04010Cutting Edge Spine, LLCMAX00841193120737