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FDA 510(k)

ORTHO-WRAP BIORESORBABLE SHEET

K-Number: K072190 · 2008-01-16

ApplicantMast Biosurgery
Decision Date2008-01-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHO-WRAP BIORESORBABLE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Mast Biosurgery. It received FDA 510(k) clearance on 2008-01-16 under 510(k) number K072190. 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 ORTHO-WRAP BIORESORBABLE SHEET?

ORTHO-WRAP BIORESORBABLE SHEET is a medical device that received FDA 510(k) clearance on 2008-01-16. The listed applicant is Mast Biosurgery. The 510(k) number is K072190.

When did ORTHO-WRAP BIORESORBABLE SHEET receive FDA 510(k) clearance?

ORTHO-WRAP BIORESORBABLE SHEET received FDA 510(k) clearance on 2008-01-16, under 510(k) number K072190.

Who is the listed applicant for ORTHO-WRAP BIORESORBABLE SHEET?

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

What is the FDA product code for ORTHO-WRAP BIORESORBABLE SHEET?

The FDA product code for ORTHO-WRAP BIORESORBABLE SHEET 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 Mast Biosurgery 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.

K200918SurgiWrap FROST

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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