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FDA 510(k)

TOTAL SHOULDER PROSTHESIS

K-Number: K950651 · 1995-05-30

ApplicantEncore Orthopedics, Inc.
Decision Date1995-05-30
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TOTAL SHOULDER PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1995-05-30 under 510(k) number K950651. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the TOTAL SHOULDER PROSTHESIS?

TOTAL SHOULDER PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-05-30. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K950651.

When did TOTAL SHOULDER PROSTHESIS receive FDA 510(k) clearance?

TOTAL SHOULDER PROSTHESIS received FDA 510(k) clearance on 1995-05-30, under 510(k) number K950651.

Who is the listed applicant for TOTAL SHOULDER PROSTHESIS?

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

What is the FDA product code for TOTAL SHOULDER PROSTHESIS?

The FDA product code for TOTAL SHOULDER PROSTHESIS is KWS.

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Related Devices (Code: KWS)

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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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