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FDA 510(k)

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER

K-Number: K071577 · 2007-09-06

ApplicantBiomet Microfixation, Inc.
Decision Date2007-09-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER 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 2007-09-06 under 510(k) number K071577. 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 LACTOSORB PECTUS STABILIZER?

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER is a medical device that received FDA 510(k) clearance on 2007-09-06. The listed applicant is Biomet Microfixation, Inc.. The 510(k) number is K071577.

When did BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER receive FDA 510(k) clearance?

BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER received FDA 510(k) clearance on 2007-09-06, under 510(k) number K071577.

Who is the listed applicant for BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER?

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 LACTOSORB PECTUS STABILIZER?

The FDA product code for BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER 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 SYSTEMK110574BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEMK091058ADKINS STRUTK081067FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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