FDA 510(k)

3DMax MID Anatomical Mesh

K-Number: K200818 · 2020-07-17

Decision Date2020-07-17

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

3DMax MID Anatomical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2020-07-17 under 510(k) number K200818. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DMax MID Anatomical Mesh?

3DMax MID Anatomical Mesh is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K200818.

When did 3DMax MID Anatomical Mesh receive FDA 510(k) clearance?

3DMax MID Anatomical Mesh received FDA 510(k) clearance on 2020-07-17, under 510(k) number K200818.

Who is the listed applicant for 3DMax MID Anatomical Mesh?

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

What is the FDA product code for 3DMax MID Anatomical Mesh?

The FDA product code for 3DMax MID Anatomical Mesh is FTL.

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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.