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FDA 510(k)

Signature™ ONE System

K-Number: K212560 · 2021-10-12

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2021-10-12
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 2021-10-12 under 510(k) number K212560. 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 2021-10-12. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K212560.

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

Signature™ ONE System received FDA 510(k) clearance on 2021-10-12, under 510(k) number K212560.

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

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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.

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