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FDA 510(k)

SPORTMESH OR ARTELON TISSUE REINFORCEMENT

K-Number: K071887 · 2007-09-18

ApplicantArtimplant AB
Decision Date2007-09-18
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPORTMESH OR ARTELON TISSUE REINFORCEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Artimplant AB. It received FDA 510(k) clearance on 2007-09-18 under 510(k) number K071887. 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 SPORTMESH OR ARTELON TISSUE REINFORCEMENT?

SPORTMESH OR ARTELON TISSUE REINFORCEMENT is a medical device that received FDA 510(k) clearance on 2007-09-18. The listed applicant is Artimplant AB. The 510(k) number is K071887.

When did SPORTMESH OR ARTELON TISSUE REINFORCEMENT receive FDA 510(k) clearance?

SPORTMESH OR ARTELON TISSUE REINFORCEMENT received FDA 510(k) clearance on 2007-09-18, under 510(k) number K071887.

Who is the listed applicant for SPORTMESH OR ARTELON TISSUE REINFORCEMENT?

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

What is the FDA product code for SPORTMESH OR ARTELON TISSUE REINFORCEMENT?

The FDA product code for SPORTMESH OR ARTELON TISSUE REINFORCEMENT is FTL.

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Other records listing Artimplant AB 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.

K061956ARTELON STT SPACERK061954ARTELON CMC SPACER ARTHROK052830SPORTMESHK052482ARTELON SURGICAL SUTUREK040070ARTELON SPACER CMC-1K032160ARTELON SURGICAL SUTURE

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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

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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