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FDA 510(k)

Efficient Care 3D Planning

K-Number: K183544 · 2019-08-23

ApplicantOrthosoft Inc (D/B/A Zimmer Cas)
Decision Date2019-08-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Efficient Care 3D Planning 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 2019-08-23 under 510(k) number K183544. 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 Efficient Care 3D Planning?

Efficient Care 3D Planning is a medical device that received FDA 510(k) clearance on 2019-08-23. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K183544.

When did Efficient Care 3D Planning receive FDA 510(k) clearance?

Efficient Care 3D Planning received FDA 510(k) clearance on 2019-08-23, under 510(k) number K183544.

Who is the listed applicant for Efficient Care 3D Planning?

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 Efficient Care 3D Planning?

The FDA product code for Efficient Care 3D Planning is LLZ.

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

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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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