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FDA 510(k)

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM

K-Number: K060156 · 2006-03-20

ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Decision Date2006-03-20
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW 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 2006-03-20 under 510(k) number K060156. 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 STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM?

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-20. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. The 510(k) number is K060156.

When did STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM receive FDA 510(k) clearance?

STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM received FDA 510(k) clearance on 2006-03-20, under 510(k) number K060156.

Who is the listed applicant for STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW 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 STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM?

The FDA product code for STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW 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.

K093868I.T.S. LRS LOCKING RECONSTRUCTION SYSTEMK080706CONNEXX LOCKING TIBIA NAILK080184DISTAL HUMERAL PLATES WITH ANGULAR STABILITYK063672FIBULA PLATE PROLOCK WITH ANGULAR STABILITYK063166I.T.S. PELVIC RECONSTRUCTION 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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