FDA 510(k)

ShefaBone SCPC Resorbable Bone Graft

K-Number: K153230 · 2016-07-14

Decision Date2016-07-14

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ShefaBone SCPC Resorbable Bone Graft is a medical device manufactured by The Implantech Inc./Shefabone. It received FDA 510(k) clearance on 2016-07-14 under approval number K153230. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ShefaBone SCPC Resorbable Bone Graft?

ShefaBone SCPC Resorbable Bone Graft is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by The Implantech Inc./Shefabone. The 510(k) number is K153230.

When was ShefaBone SCPC Resorbable Bone Graft approved by the FDA?

ShefaBone SCPC Resorbable Bone Graft received FDA 510(k) clearance on 2016-07-14, under approval number K153230.

What company makes ShefaBone SCPC Resorbable Bone Graft?

ShefaBone SCPC Resorbable Bone Graft is manufactured by The Implantech Inc./Shefabone.

What is the FDA product code for ShefaBone SCPC Resorbable Bone Graft?

The FDA product code for ShefaBone SCPC Resorbable Bone Graft is LYC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.