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FDA 510(k)

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM

K-Number: K110039 · 2011-05-03

ApplicantBiomet Sports Medicine
Decision Date2011-05-03
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET SPORTS MEDICINE STERNAL CLOSURE 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 2011-05-03 under 510(k) number K110039. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM?

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-03. The listed applicant is Biomet Sports Medicine. The 510(k) number is K110039.

When did BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM receive FDA 510(k) clearance?

BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM received FDA 510(k) clearance on 2011-05-03, under 510(k) number K110039.

Who is the listed applicant for BIOMET SPORTS MEDICINE STERNAL CLOSURE 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 BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM?

The FDA product code for BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM is JDQ.

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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 DEVICEK103145HAMMERLOC TM TIBIAL FIXATION DEVICEK101063SLEEVE WITH ZIPLOOP FIXATION DEVICES

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Related Devices (Code: JDQ)

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.

K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.K243905Stitch Cerclage – Suture TapesGM Dos Reis Industria e Comercio Ltda.K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage SuturesArthrex, Inc.K232733Mbrace CableMedacta International S.A.K233949ACCORD Cable SystemSmith & Nephew, Inc.K232986VariTrax Sternal CircumFixation SystemCircumfix Solutions, 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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