
Wenzel Spine, Inc.
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primaLOK SP Interspinous Fusion System is an FDA 510(k)-cleared medical device (K231807) manufactured by Wenzel Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2023. Regulation: 8.

Synthes (Usa)
SKU K100676
BackorderedMedline
SKU VM-1270020

Cardinal Health
SKU VM-1270026
BackorderedMoog
SKU VM-1270057