FDA Clearance Letters

HV Screw System 510(k) Clearance Letter (K170889)

HV Screw System 510(k) Clearance Letter (K170889)

Primado2 Total Surgical System 510(k) Clearance Letter (K132264)

PROstep™ MIS Bunionette Clearance Letter (K190970)

Supporting Clinical Evidence


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  • Dhukaram, V. ET AL. | Foot Ankle Int. 2012

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  • Durston, A. ET AL. | J. Foot Ankle Surg. 2015

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  • Jowett, CRJ. ET AL. | J. Foot Ankle Surg. 2017

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  • Kheir, E. ET AL. | Foot Ankle Int. 2015

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  • LAI, MC. ET AL. | Foot Ankle Int. 2018

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  • Lam, P. ET AL. | Foot Ankle Clin 2016

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  • Lee, M. ET AL. | Foot Ankle Int. 2017

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  • Miller, RJ. ET AL. | Foot Ankle Clin 2016

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  • Muffulli, N. ET AL. | Orthop Clin North Am 2009

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  • Razik, A. ET AL. | Foot Ankle Clin 2016

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  • Redfern, D. ET AL. | Clin Podiatr Med Surg 2015

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  • REDFERN, D. ET AL. | TECH F&A SURG. 2016

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  • Sott, AH. ET AL. | Foot Ankle Clin 2016

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  • Vernois, J. ET AL. | Foot Ankle Clin 2016

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