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FDA 510(k)

SLEEVE AND BUTTON SOFT TISSUE DEVICES

K-Number: K071704 · 2007-09-17

ApplicantBiomet Sports Medicine, Inc.
Decision Date2007-09-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLEEVE AND BUTTON SOFT TISSUE DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Sports Medicine, Inc.. It received FDA 510(k) clearance on 2007-09-17 under 510(k) number K071704. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEVE AND BUTTON SOFT TISSUE DEVICES?

SLEEVE AND BUTTON SOFT TISSUE DEVICES is a medical device that received FDA 510(k) clearance on 2007-09-17. The listed applicant is Biomet Sports Medicine, Inc.. The 510(k) number is K071704.

When did SLEEVE AND BUTTON SOFT TISSUE DEVICES receive FDA 510(k) clearance?

SLEEVE AND BUTTON SOFT TISSUE DEVICES received FDA 510(k) clearance on 2007-09-17, under 510(k) number K071704.

Who is the listed applicant for SLEEVE AND BUTTON SOFT TISSUE DEVICES?

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

What is the FDA product code for SLEEVE AND BUTTON SOFT TISSUE DEVICES?

The FDA product code for SLEEVE AND BUTTON SOFT TISSUE DEVICES is MBI.

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Other records listing Biomet Sports Medicine, 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.

K071816HARPOON SUTURE ANCHORK070389PEEK KNOTLESS ANCHORSK071498SUBTALAR IMPLANT

Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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