FDA 510(k)

MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS

K-Number: K030344 · 2003-03-04

Decision Date2003-03-04

Product CodeKWS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2003-03-04 under 510(k) number K030344. 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 MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS?

MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2003-03-04. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K030344.

When did MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS receive FDA 510(k) clearance?

MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS received FDA 510(k) clearance on 2003-03-04, under 510(k) number K030344.

Who is the listed applicant for MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS?

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

What is the FDA product code for MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS?

The FDA product code for MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS is KWS.

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Related Devices (Code: KWS)

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.