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FDA 510(k)

EXACTECH EQUINOXE SHOULDER STEMS

K-Number: K061454 · 2006-06-12

ApplicantExactech, Inc.
Decision Date2006-06-12
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH EQUINOXE SHOULDER STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2006-06-12 under 510(k) number K061454. 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 EXACTECH EQUINOXE SHOULDER STEMS?

EXACTECH EQUINOXE SHOULDER STEMS is a medical device that received FDA 510(k) clearance on 2006-06-12. The listed applicant is Exactech, Inc.. The 510(k) number is K061454.

When did EXACTECH EQUINOXE SHOULDER STEMS receive FDA 510(k) clearance?

EXACTECH EQUINOXE SHOULDER STEMS received FDA 510(k) clearance on 2006-06-12, under 510(k) number K061454.

Who is the listed applicant for EXACTECH EQUINOXE SHOULDER STEMS?

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

What is the FDA product code for EXACTECH EQUINOXE SHOULDER STEMS?

The FDA product code for EXACTECH EQUINOXE SHOULDER STEMS is HSD.

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Other records listing Exactech, Inc. 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.

K260583Equinoxe® Shoulder SystemK250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsK243448Equinoxe® Shoulder SystemK243275Equinoxe® Scapula Fracture SystemK243839Alteon® HA Femoral StemsK240393Exactech® TRULIANT® Knee System

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Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.

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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