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FDA 510(k)

Small Bone Nailing System

K-Number: K211439 · 2021-09-30

ApplicantSkeletal Dynamics, Inc.
Decision Date2021-09-30
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Small Bone Nailing System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2021-09-30 under approval number K211439. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Small Bone Nailing System?

Small Bone Nailing System is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K211439.

When was Small Bone Nailing System approved by the FDA?

Small Bone Nailing System received FDA 510(k) clearance on 2021-09-30, under approval number K211439.

What company makes Small Bone Nailing System?

Small Bone Nailing System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Small Bone Nailing System?

The FDA product code for Small Bone Nailing System is HTY.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by Skeletal Dynamics, Inc.

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Related Devices (Code: HTY)

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Official Source

View on FDA Database →

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

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