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FDA 510(k)

DARCO LOCKING BONE PLATE SYSTEM

K-Number: K061808 · 2006-08-17

ApplicantDarco International, Inc.
Decision Date2006-08-17
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DARCO LOCKING BONE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Darco International, Inc.. It received FDA 510(k) clearance on 2006-08-17 under 510(k) number K061808. 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 DARCO LOCKING BONE PLATE SYSTEM?

DARCO LOCKING BONE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-17. The listed applicant is Darco International, Inc.. The 510(k) number is K061808.

When did DARCO LOCKING BONE PLATE SYSTEM receive FDA 510(k) clearance?

DARCO LOCKING BONE PLATE SYSTEM received FDA 510(k) clearance on 2006-08-17, under 510(k) number K061808.

Who is the listed applicant for DARCO LOCKING BONE PLATE SYSTEM?

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

What is the FDA product code for DARCO LOCKING BONE PLATE SYSTEM?

The FDA product code for DARCO LOCKING BONE PLATE SYSTEM is HRS.

Related Clinical Trials

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.

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Other records listing Darco International, 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.

K062103DARCO FORCE TITANIUM COMPRESSION 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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