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FDA 510(k)

3DMatrix Surgical Mesh

K-Number: K232602 · 2024-05-23

ApplicantPrintbio, Inc.
Decision Date2024-05-23
Product CodeOXF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3DMatrix Surgical Mesh is a medical device manufactured by Printbio, Inc.. It received FDA 510(k) clearance on 2024-05-23 under approval number K232602. 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 Surgical Mesh?

3DMatrix Surgical Mesh is a medical device that received FDA 510(k) clearance on 2024-05-23. It is manufactured by Printbio, Inc.. The 510(k) number is K232602.

When was 3DMatrix Surgical Mesh approved by the FDA?

3DMatrix Surgical Mesh received FDA 510(k) clearance on 2024-05-23, under approval number K232602.

What company makes 3DMatrix Surgical Mesh?

3DMatrix Surgical Mesh is manufactured by Printbio, Inc..

What is the FDA product code for 3DMatrix Surgical Mesh?

The FDA product code for 3DMatrix Surgical Mesh is OXF.

Other Devices by Printbio, Inc.

K2433023DMatrix DynaFlex (DynaFlex)

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. K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. K2433023DMatrix DynaFlex (DynaFlex)Printbio, 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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