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FDA 510(k)

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

K-Number: K103007 · 2010-11-09

ApplicantTornier, Inc.
Decision Date2010-11-09
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2010-11-09 under 510(k) number K103007. 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 AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM?

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM is a medical device that received FDA 510(k) clearance on 2010-11-09. The listed applicant is Tornier, Inc.. The 510(k) number is K103007.

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

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM received FDA 510(k) clearance on 2010-11-09, under 510(k) number K103007.

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

The FDA 510(k) record lists Tornier, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Other records listing Tornier, Inc. 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.

K260721Tornier Perform Advanced GlenoidK252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)K230352Tornier Humeral Nail and Tornier Long Humeral NailK220914Tornier Perform Humeral System – FractureK220418Tornier Perform Humeral System – Stemless

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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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