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

FDA 510(k)

Signature™ ONE System

K-Number: K232425 · 2023-12-12

ApplicantOrthosoft Inc. (D/B/A) Zimmer Cas)
Decision Date2023-12-12
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Signature™ ONE System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc. (D/B/A) Zimmer Cas). It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K232425. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signature™ ONE System?

Signature™ ONE System is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Orthosoft Inc. (D/B/A) Zimmer Cas). The 510(k) number is K232425.

When did Signature™ ONE System receive FDA 510(k) clearance?

Signature™ ONE System received FDA 510(k) clearance on 2023-12-12, under 510(k) number K232425.

Who is the listed applicant for Signature™ ONE System?

The FDA 510(k) record lists Orthosoft Inc. (D/B/A) Zimmer Cas) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signature™ ONE System?

The FDA product code for Signature™ ONE System is QHE.

Other records listing Orthosoft Inc. (D/B/A) Zimmer Cas) 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.

K261510Signature™ ONE SystemK260582ROSA® Shoulder SystemK260104Signature™ ONE SystemK251314Rosa® Knee SystemK242864ROSA® Knee SystemK233199ROSA® Shoulder System

View all 20 devices →

Related Devices (Code: QHE)

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.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.

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.

↑