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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 the device name listed in this FDA 510(k) record. The listed applicant is Printbio, Inc.. It received FDA 510(k) clearance on 2024-05-23 under 510(k) 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. The listed applicant is Printbio, Inc.. The 510(k) number is K232602.

When did 3DMatrix Surgical Mesh receive FDA 510(k) clearance?

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

Who is the listed applicant for 3DMatrix Surgical Mesh?

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

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

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

Other records listing Printbio, 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.

K2433023DMatrix DynaFlex (DynaFlex)

Related Devices (Code: OXF)

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.

K251224Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc.K2433023DMatrix DynaFlex (DynaFlex)Printbio, Inc.K222919GORE® ENFORM BiomaterialW. L. Gore and Associates, Inc.K173333GORE ENFORM BiomaterialW. L. Gore & Associates, Inc.K172545SERI ContourSofregen Medical, Inc.K163217GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, 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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