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FDA 510(k)

TOTAL AND HEMI SHOULDER SYSTEM

K-Number: K060988 · 2006-12-06

ApplicantDvo Extremity Solutions, LLC
Decision Date2006-12-06
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOTAL AND HEMI SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dvo Extremity Solutions, LLC. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K060988. 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 TOTAL AND HEMI SHOULDER SYSTEM?

TOTAL AND HEMI SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Dvo Extremity Solutions, LLC. The 510(k) number is K060988.

When did TOTAL AND HEMI SHOULDER SYSTEM receive FDA 510(k) clearance?

TOTAL AND HEMI SHOULDER SYSTEM received FDA 510(k) clearance on 2006-12-06, under 510(k) number K060988.

Who is the listed applicant for TOTAL AND HEMI SHOULDER SYSTEM?

The FDA 510(k) record lists Dvo Extremity Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL AND HEMI SHOULDER SYSTEM?

The FDA product code for TOTAL AND HEMI SHOULDER SYSTEM is KWS.

Related Clinical Trials

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.

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Other records listing Dvo Extremity Solutions, LLC 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.

K073331DVO EXTENDED ARTICULATION HUMERAL HEADSK052754WRIST FUSION PLATEK052150VOLAR PLATE SYSTEM

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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