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FDA 510(k)

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT

K-Number: K103104 · 2010-11-22

ApplicantHowmedica Osteonics Corp.
Decision Date2010-11-22
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2010-11-22 under 510(k) number K103104. 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 SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT?

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT is a medical device that received FDA 510(k) clearance on 2010-11-22. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K103104.

When did SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT receive FDA 510(k) clearance?

SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT received FDA 510(k) clearance on 2010-11-22, under 510(k) number K103104.

Who is the listed applicant for SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT?

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

What is the FDA product code for SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT?

The FDA product code for SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT 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

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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