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FDA 510(k)

OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD

K-Number: K990598 · 1999-03-15

ApplicantHowmedica Osteonics Corp.
Decision Date1999-03-15
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD 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 1999-03-15 under 510(k) number K990598. 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 OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD?

OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD is a medical device that received FDA 510(k) clearance on 1999-03-15. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K990598.

When did OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD receive FDA 510(k) clearance?

OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD received FDA 510(k) clearance on 1999-03-15, under 510(k) number K990598.

Who is the listed applicant for OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD?

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 OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD?

The FDA product code for OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD 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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