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FDA 510(k)

SLEEVE WITH ZIPLOOP FIXATION DEVICES

K-Number: K101063 · 2010-06-23

ApplicantBiomet Sports Medicine
Decision Date2010-06-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SLEEVE WITH ZIPLOOP FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Sports Medicine. It received FDA 510(k) clearance on 2010-06-23 under 510(k) number K101063. 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 WITH ZIPLOOP FIXATION DEVICES?

SLEEVE WITH ZIPLOOP FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Biomet Sports Medicine. The 510(k) number is K101063.

When did SLEEVE WITH ZIPLOOP FIXATION DEVICES receive FDA 510(k) clearance?

SLEEVE WITH ZIPLOOP FIXATION DEVICES received FDA 510(k) clearance on 2010-06-23, under 510(k) number K101063.

Who is the listed applicant for SLEEVE WITH ZIPLOOP FIXATION DEVICES?

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

What is the FDA product code for SLEEVE WITH ZIPLOOP FIXATION DEVICES?

The FDA product code for SLEEVE WITH ZIPLOOP FIXATION DEVICES is MBI.

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Other records listing Biomet Sports Medicine 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.

K122437NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERSK123485JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOFK110879BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHORK111564MAXFIRE MARXMEN MENISCAL REPAIR DEVICEK110039BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEMK103145HAMMERLOC TM TIBIAL FIXATION DEVICE

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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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