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FDA 510(k)

GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00

K-Number: K043346 · 2005-01-31

ApplicantGenesis Medical LLC
Decision Date2005-01-31
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Medical LLC. It received FDA 510(k) clearance on 2005-01-31 under 510(k) number K043346. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00?

GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 is a medical device that received FDA 510(k) clearance on 2005-01-31. The listed applicant is Genesis Medical LLC. The 510(k) number is K043346.

When did GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 receive FDA 510(k) clearance?

GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 received FDA 510(k) clearance on 2005-01-31, under 510(k) number K043346.

Who is the listed applicant for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00?

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

What is the FDA product code for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00?

The FDA product code for GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 is KWS.

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Related Devices (Code: KWS)

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.

K260721Tornier Perform Advanced GlenoidTornier, Inc.K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)Stryker Corporation (Tornier, 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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