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FDA 510(k)

SOLAR REUNION FRACTURE STEM

K-Number: K062113 · 2006-10-03

ApplicantHowmedica Osteonics Corp.
Decision Date2006-10-03
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLAR REUNION FRACTURE STEM 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 2006-10-03 under 510(k) number K062113. 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 SOLAR REUNION FRACTURE STEM?

SOLAR REUNION FRACTURE STEM is a medical device that received FDA 510(k) clearance on 2006-10-03. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K062113.

When did SOLAR REUNION FRACTURE STEM receive FDA 510(k) clearance?

SOLAR REUNION FRACTURE STEM received FDA 510(k) clearance on 2006-10-03, under 510(k) number K062113.

Who is the listed applicant for SOLAR REUNION FRACTURE STEM?

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 SOLAR REUNION FRACTURE STEM?

The FDA product code for SOLAR REUNION FRACTURE STEM 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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