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FDA 510(k)

NAVIPLAN - CT Planning Software for Total Hip Replacement

K-Number: K211429 · 2021-10-05

ApplicantNaviswiss AG
Decision Date2021-10-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NAVIPLAN - CT Planning Software for Total Hip Replacement is a medical device manufactured by Naviswiss AG. It received FDA 510(k) clearance on 2021-10-05 under approval number K211429. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIPLAN - CT Planning Software for Total Hip Replacement?

NAVIPLAN - CT Planning Software for Total Hip Replacement is a medical device that received FDA 510(k) clearance on 2021-10-05. It is manufactured by Naviswiss AG. The 510(k) number is K211429.

When was NAVIPLAN - CT Planning Software for Total Hip Replacement approved by the FDA?

NAVIPLAN - CT Planning Software for Total Hip Replacement received FDA 510(k) clearance on 2021-10-05, under approval number K211429.

What company makes NAVIPLAN - CT Planning Software for Total Hip Replacement?

NAVIPLAN - CT Planning Software for Total Hip Replacement is manufactured by Naviswiss AG.

What is the FDA product code for NAVIPLAN - CT Planning Software for Total Hip Replacement?

The FDA product code for NAVIPLAN - CT Planning Software for Total Hip Replacement is LLZ.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06298305 Artificial Intelligence & Prostate Cancer COMPLETED NCT07564427 Effects of Additional High-Intensity Pulsed Electromagnetic Field (HI-PEMF) Therapy on Pain and Physical Function After Total Hip Replacement NOT_YET_RECRUITING NCT05357378 Safety and Effectiveness of the HIT Reverse HRS RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

Other Devices by Naviswiss AG

K193094Naviswiss Hip Navigation System K223351Naviswiss Knee

Related Devices (Code: LLZ)

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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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