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FDA 510(k)

AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM

K-Number: K061862 · 2006-08-28

ApplicantAxiom Orthopaedics, Inc.
Decision Date2006-08-28
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Orthopaedics, Inc.. It received FDA 510(k) clearance on 2006-08-28 under 510(k) number K061862. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM?

AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM is a medical device that received FDA 510(k) clearance on 2006-08-28. The listed applicant is Axiom Orthopaedics, Inc.. The 510(k) number is K061862.

When did AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM receive FDA 510(k) clearance?

AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM received FDA 510(k) clearance on 2006-08-28, under 510(k) number K061862.

Who is the listed applicant for AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM?

The FDA 510(k) record lists Axiom Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM?

The FDA product code for AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM is HSD.

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Related Devices (Code: HSD)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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