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FDA 510(k)

HUMELOCK II CEMENTLESS SHOULDER SYSTEM

K-Number: K130759 · 2013-11-09

ApplicantFx Solutions
Decision Date2013-11-09
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HUMELOCK II CEMENTLESS SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fx Solutions. It received FDA 510(k) clearance on 2013-11-09 under 510(k) number K130759. 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 HUMELOCK II CEMENTLESS SHOULDER SYSTEM?

HUMELOCK II CEMENTLESS SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-09. The listed applicant is Fx Solutions. The 510(k) number is K130759.

When did HUMELOCK II CEMENTLESS SHOULDER SYSTEM receive FDA 510(k) clearance?

HUMELOCK II CEMENTLESS SHOULDER SYSTEM received FDA 510(k) clearance on 2013-11-09, under 510(k) number K130759.

Who is the listed applicant for HUMELOCK II CEMENTLESS SHOULDER SYSTEM?

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

What is the FDA product code for HUMELOCK II CEMENTLESS SHOULDER SYSTEM?

The FDA product code for HUMELOCK II CEMENTLESS SHOULDER SYSTEM is HSD.

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Other records listing Fx Solutions 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.

K163669Humeris ShoulderK162455Humelock Reversed ShoulderK123814HUMELOCK II CEMENTED SHOULDER SYSTEMK111097HUMELOCK CEMENTED SHOULDER PROSTHESIS

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

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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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