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FDA 510(k)

APTUS TITANIUM OSTEOSYNTHESIS SYSTEM

K-Number: K051567 · 2005-08-23

ApplicantMedartis, Inc.
Decision Date2005-08-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APTUS TITANIUM OSTEOSYNTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medartis, Inc.. It received FDA 510(k) clearance on 2005-08-23 under 510(k) number K051567. 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 APTUS TITANIUM OSTEOSYNTHESIS SYSTEM?

APTUS TITANIUM OSTEOSYNTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-23. The listed applicant is Medartis, Inc.. The 510(k) number is K051567.

When did APTUS TITANIUM OSTEOSYNTHESIS SYSTEM receive FDA 510(k) clearance?

APTUS TITANIUM OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance on 2005-08-23, under 510(k) number K051567.

Who is the listed applicant for APTUS TITANIUM OSTEOSYNTHESIS SYSTEM?

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

What is the FDA product code for APTUS TITANIUM OSTEOSYNTHESIS SYSTEM?

The FDA product code for APTUS TITANIUM OSTEOSYNTHESIS SYSTEM is HRS.

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Other records listing Medartis, 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.

K232324StealthFix Intraosseous Fixation SystemK052061MODUS IMF SCREWS 2.0K051946MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEMK050934MODUS TITANIUM OSTEOSYNTHESIS SYSTEM

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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