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FDA 510(k)

3DMatrix DynaFlex (DynaFlex)

K-Number: K243302 · 2025-05-21

ApplicantPrintbio, Inc.
Decision Date2025-05-21
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3DMatrix DynaFlex (DynaFlex) is a medical device manufactured by Printbio, Inc.. It received FDA 510(k) clearance on 2025-05-21 under approval number K243302. The device is classified under product code OXF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DMatrix DynaFlex (DynaFlex)?

3DMatrix DynaFlex (DynaFlex) is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Printbio, Inc.. The 510(k) number is K243302.

When was 3DMatrix DynaFlex (DynaFlex) approved by the FDA?

3DMatrix DynaFlex (DynaFlex) received FDA 510(k) clearance on 2025-05-21, under approval number K243302.

What company makes 3DMatrix DynaFlex (DynaFlex)?

3DMatrix DynaFlex (DynaFlex) is manufactured by Printbio, Inc..

What is the FDA product code for 3DMatrix DynaFlex (DynaFlex)?

The FDA product code for 3DMatrix DynaFlex (DynaFlex) is OXF.

Other Devices by Printbio, Inc.

K2326023DMatrix Surgical Mesh

Related Devices (Code: OXF)

K172545SERI ContourSofregen Medical, Inc. K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc. K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc. K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc. K2326023DMatrix Surgical MeshPrintbio, Inc. K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.

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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