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FDA 510(k)

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM

K-Number: K120163 · 2012-02-17

ApplicantAcute Innovations, LLC
Decision Date2012-02-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acute Innovations, LLC. It received FDA 510(k) clearance on 2012-02-17 under 510(k) number K120163. 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 ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM?

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-17. The listed applicant is Acute Innovations, LLC. The 510(k) number is K120163.

When did ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM receive FDA 510(k) clearance?

ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM received FDA 510(k) clearance on 2012-02-17, under 510(k) number K120163.

Who is the listed applicant for ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM?

The FDA 510(k) record lists Acute Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM?

The FDA product code for ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM is HRS.

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Other records listing Acute Innovations, LLC 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.

K113318ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMK101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEMK081588RE-ZORB PLATING SYSTEMK061206ACUTE BONE SCREW

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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