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FDA 510(k)

HUMELOCK CEMENTED SHOULDER PROSTHESIS

K-Number: K111097 · 2011-11-09

ApplicantFx Solutions
Decision Date2011-11-09
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HUMELOCK CEMENTED SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Fx Solutions. It received FDA 510(k) clearance on 2011-11-09 under 510(k) number K111097. 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 CEMENTED SHOULDER PROSTHESIS?

HUMELOCK CEMENTED SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 2011-11-09. The listed applicant is Fx Solutions. The 510(k) number is K111097.

When did HUMELOCK CEMENTED SHOULDER PROSTHESIS receive FDA 510(k) clearance?

HUMELOCK CEMENTED SHOULDER PROSTHESIS received FDA 510(k) clearance on 2011-11-09, under 510(k) number K111097.

Who is the listed applicant for HUMELOCK CEMENTED SHOULDER PROSTHESIS?

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 CEMENTED SHOULDER PROSTHESIS?

The FDA product code for HUMELOCK CEMENTED SHOULDER PROSTHESIS 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 ShoulderK130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMK123814HUMELOCK II CEMENTED SHOULDER SYSTEM

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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