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FDA 510(k)

PILONPLATE WITH ANGULAR STABILITY

K-Number: K052011 · 2005-08-10

ApplicantI.T.S. Implantat-Technologie-Systeme GmbH
Decision Date2005-08-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PILONPLATE WITH ANGULAR STABILITY 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 2005-08-10 under 510(k) number K052011. 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 PILONPLATE WITH ANGULAR STABILITY?

PILONPLATE WITH ANGULAR STABILITY is a medical device that received FDA 510(k) clearance on 2005-08-10. The listed applicant is I.T.S. Implantat-Technologie-Systeme GmbH. The 510(k) number is K052011.

When did PILONPLATE WITH ANGULAR STABILITY receive FDA 510(k) clearance?

PILONPLATE WITH ANGULAR STABILITY received FDA 510(k) clearance on 2005-08-10, under 510(k) number K052011.

Who is the listed applicant for PILONPLATE WITH ANGULAR STABILITY?

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 PILONPLATE WITH ANGULAR STABILITY?

The FDA product code for PILONPLATE WITH ANGULAR STABILITY 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 SYSTEMK060156STRAIGHT PLATE WITH ANGULAR STABILITY & 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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