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FDA 510(k)

Deformity Analysis and Correction Software (DACS) and Instrumentation

K-Number: K180539 · 2018-08-13

ApplicantArrowhead Medical Device Technologies, LLC
Decision Date2018-08-13
Product CodeOSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Deformity Analysis and Correction Software (DACS) and Instrumentation is a medical device manufactured by Arrowhead Medical Device Technologies, LLC. It received FDA 510(k) clearance on 2018-08-13 under approval number K180539. The device is classified under product code OSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deformity Analysis and Correction Software (DACS) and Instrumentation?

Deformity Analysis and Correction Software (DACS) and Instrumentation is a medical device that received FDA 510(k) clearance on 2018-08-13. It is manufactured by Arrowhead Medical Device Technologies, LLC. The 510(k) number is K180539.

When was Deformity Analysis and Correction Software (DACS) and Instrumentation approved by the FDA?

Deformity Analysis and Correction Software (DACS) and Instrumentation received FDA 510(k) clearance on 2018-08-13, under approval number K180539.

What company makes Deformity Analysis and Correction Software (DACS) and Instrumentation?

Deformity Analysis and Correction Software (DACS) and Instrumentation is manufactured by Arrowhead Medical Device Technologies, LLC.

What is the FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation?

The FDA product code for Deformity Analysis and Correction Software (DACS) and Instrumentation is OSN.

Related Clinical Trials

NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07589829 The Effects of Kinesio Taping on Hallux Valgus COMPLETED NCT07586683 OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41635818 Correction: Interventional effects of mesenchymal stem cells on epithelial-mesenchymal transition in head and neck squamous cell carcinoma and underlying mechanisms: a systematic review and meta-analysis of Frontiers in immunology (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026)

Related Devices (Code: OSN)

K221792Acute QC Strut and ComponentsSmith & Nephew, Inc. K253764ENOS Software Guided External Fixation SystemDisior, Ltd.

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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