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FDA 510(k)

ACUMED TOTALW RIST FUSION PLATING SYSTEM

K-Number: K131380 · 2013-06-10

ApplicantAcumed, LLC
Decision Date2013-06-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUMED TOTALW RIST FUSION PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2013-06-10 under 510(k) number K131380. 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 ACUMED TOTALW RIST FUSION PLATING SYSTEM?

ACUMED TOTALW RIST FUSION PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-10. The listed applicant is Acumed, LLC. The 510(k) number is K131380.

When did ACUMED TOTALW RIST FUSION PLATING SYSTEM receive FDA 510(k) clearance?

ACUMED TOTALW RIST FUSION PLATING SYSTEM received FDA 510(k) clearance on 2013-06-10, under 510(k) number K131380.

Who is the listed applicant for ACUMED TOTALW RIST FUSION PLATING SYSTEM?

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

What is the FDA product code for ACUMED TOTALW RIST FUSION PLATING SYSTEM?

The FDA product code for ACUMED TOTALW RIST FUSION PLATING SYSTEM is HRS.

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Other records listing Acumed, 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.

K252356The Acumed Wrist Fixation System - 2.4mm ScrewsK251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsK251296The Acumed Wrist Fixation SystemK243624Acu-Sinch Knotless MiniK233311Acumed Wrist Plating SystemK230744Acumed Acutrak 3 Headless Compression Screw System

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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

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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