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FDA 510(k)

BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

K-Number: K110574 · 2011-05-18

ApplicantBiomet Microfixation, Inc.
Decision Date2011-05-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation, Inc.. It received FDA 510(k) clearance on 2011-05-18 under 510(k) number K110574. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM?

BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-18. The listed applicant is Biomet Microfixation, Inc.. The 510(k) number is K110574.

When did BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM receive FDA 510(k) clearance?

BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM received FDA 510(k) clearance on 2011-05-18, under 510(k) number K110574.

Who is the listed applicant for BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM?

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

What is the FDA product code for BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM?

The FDA product code for BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM is HRS.

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Other records listing Biomet Microfixation, 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.

K111908BIOMET MICROFIXATION STERNAL CLOSURE SYSTEMK091058ADKINS STRUTK081067FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)K071577BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Official Source

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