Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Clevaligner Software (V1.0.0)

K-Number: K233616 · 2024-01-11

ApplicantClevaligner, Ltd.
Decision Date2024-01-11
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clevaligner Software (V1.0.0) is a medical device manufactured by Clevaligner, Ltd.. It received FDA 510(k) clearance on 2024-01-11 under approval number K233616. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clevaligner Software (V1.0.0)?

Clevaligner Software (V1.0.0) is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Clevaligner, Ltd.. The 510(k) number is K233616.

When was Clevaligner Software (V1.0.0) approved by the FDA?

Clevaligner Software (V1.0.0) received FDA 510(k) clearance on 2024-01-11, under approval number K233616.

What company makes Clevaligner Software (V1.0.0)?

Clevaligner Software (V1.0.0) is manufactured by Clevaligner, Ltd..

What is the FDA product code for Clevaligner Software (V1.0.0)?

The FDA product code for Clevaligner Software (V1.0.0) is PNN.

Related Devices (Code: PNN)

K1520863Shape Ortho System3Shape A/S K163677Ortho System3Shape A/S K162850GuideMia Ortho+Guidemia Technologies, LLC K181112Orchestrate 3DOrchestrate 3D K180941Ortho System3Shape A/S K171634Ortho System3Shape A/S

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.

↑