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FDA 510(k)

NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS

K-Number: K122437 · 2013-10-18

ApplicantBiomet Sports Medicine
Decision Date2013-10-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS 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 2013-10-18 under 510(k) number K122437. 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 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS?

NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS is a medical device that received FDA 510(k) clearance on 2013-10-18. The listed applicant is Biomet Sports Medicine. The 510(k) number is K122437.

When did NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS receive FDA 510(k) clearance?

NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS received FDA 510(k) clearance on 2013-10-18, under 510(k) number K122437.

Who is the listed applicant for NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS?

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 NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS?

The FDA product code for NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS 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.

K123485JUGGERKNOTLESS 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 DEVICEK101063SLEEVE WITH ZIPLOOP FIXATION DEVICES

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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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