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FDA 510(k)

FACIAL RECONSTRUCTIVE MESH (FRM)

K-Number: K063154 · 2007-07-10

ApplicantEvera Medical, Inc.
Decision Date2007-07-10
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FACIAL RECONSTRUCTIVE MESH (FRM) is the device name listed in this FDA 510(k) record. The listed applicant is Evera Medical, Inc.. It received FDA 510(k) clearance on 2007-07-10 under 510(k) number K063154. 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 FACIAL RECONSTRUCTIVE MESH (FRM)?

FACIAL RECONSTRUCTIVE MESH (FRM) is a medical device that received FDA 510(k) clearance on 2007-07-10. The listed applicant is Evera Medical, Inc.. The 510(k) number is K063154.

When did FACIAL RECONSTRUCTIVE MESH (FRM) receive FDA 510(k) clearance?

FACIAL RECONSTRUCTIVE MESH (FRM) received FDA 510(k) clearance on 2007-07-10, under 510(k) number K063154.

Who is the listed applicant for FACIAL RECONSTRUCTIVE MESH (FRM)?

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

What is the FDA product code for FACIAL RECONSTRUCTIVE MESH (FRM)?

The FDA product code for FACIAL RECONSTRUCTIVE MESH (FRM) is FTL.

Related Clinical Trials

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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Other records listing Evera Medical, 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.

K083342ORBITAL RECONSTRUCTIVE IMPLANT II

Related Devices (Code: FTL)

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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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