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FDA 510(k)

TOGGLELOC SYSTEM

K-Number: K083070 · 2008-12-16

ApplicantBiomet Sports Medicine
Decision Date2008-12-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOGGLELOC SYSTEM 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 2008-12-16 under 510(k) number K083070. 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 TOGGLELOC SYSTEM?

TOGGLELOC SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Biomet Sports Medicine. The 510(k) number is K083070.

When did TOGGLELOC SYSTEM receive FDA 510(k) clearance?

TOGGLELOC SYSTEM received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083070.

Who is the listed applicant for TOGGLELOC SYSTEM?

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 TOGGLELOC SYSTEM?

The FDA product code for TOGGLELOC SYSTEM 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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