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FDA 510(k)

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM

K-Number: K093868 · 2010-08-05

ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Decision Date2010-08-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. It received FDA 510(k) clearance on 2010-08-05 under 510(k) number K093868. 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 I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM?

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-05. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. The 510(k) number is K093868.

When did I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM receive FDA 510(k) clearance?

I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM received FDA 510(k) clearance on 2010-08-05, under 510(k) number K093868.

Who is the listed applicant for I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM?

The FDA 510(k) record lists I.T.S. Implantat-Technologie-Systeme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM?

The FDA product code for I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM is HRS.

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Other records listing I.T.S. Implantat-Technologie-Systeme GmbH 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.

K080706CONNEXX LOCKING TIBIA NAILK080184DISTAL HUMERAL PLATES WITH ANGULAR STABILITYK063672FIBULA PLATE PROLOCK WITH ANGULAR STABILITYK063166I.T.S. PELVIC RECONSTRUCTION SYSTEMK060156STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEMK052368OLECRANONPLATE WITH ANGULAR STABILITY

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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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