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FDA 510(k)

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE

K-Number: K120903 · 2012-07-13

ApplicantAcumed, LLC
Decision Date2012-07-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2012-07-13 under 510(k) number K120903. 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 CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE?

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Acumed, LLC. The 510(k) number is K120903.

When did CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE receive FDA 510(k) clearance?

CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE received FDA 510(k) clearance on 2012-07-13, under 510(k) number K120903.

Who is the listed applicant for CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE?

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 CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE?

The FDA product code for CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE is HRS.

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Other records listing Acumed, LLC as applicant

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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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