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FDA 510(k)

Dynanail Mini Hybrid

K-Number: K203381 · 2021-01-15

ApplicantMedShape, Inc.
Decision Date2021-01-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Dynanail Mini Hybrid is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203381. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynanail Mini Hybrid?

Dynanail Mini Hybrid is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is MedShape, Inc.. The 510(k) number is K203381.

When did Dynanail Mini Hybrid receive FDA 510(k) clearance?

Dynanail Mini Hybrid received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203381.

Who is the listed applicant for Dynanail Mini Hybrid?

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 Dynanail Mini Hybrid?

The FDA product code for Dynanail Mini Hybrid is HWC. This falls under the Cardiovascular category.

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.

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Related Devices (Code: HWC)

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.

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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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