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FDA 510(k)

DynaClip Bone Staple

K-Number: K193305 · 2020-04-23

ApplicantMedShape, Inc.
Decision Date2020-04-23
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaClip Bone Staple is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K193305. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaClip Bone Staple?

DynaClip Bone Staple is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is MedShape, Inc.. The 510(k) number is K193305.

When did DynaClip Bone Staple receive FDA 510(k) clearance?

DynaClip Bone Staple received FDA 510(k) clearance on 2020-04-23, under 510(k) number K193305.

Who is the listed applicant for DynaClip Bone Staple?

The FDA 510(k) record lists MedShape, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DynaClip Bone Staple?

The FDA product code for DynaClip Bone Staple is JDR.

Other records listing MedShape, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroK250628DynaNail TTC Fusion SystemK240530DynaNail Mini Tapered HybridK220812DynaClip® Bone StapleK203595DynaFuse Fixation SystemK203381Dynanail Mini Hybrid

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Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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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