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FDA 510(k)

FOUNDATION GLENOID COMPONENT

K-Number: K960906 · 1996-04-15

ApplicantEncore Orthopedics, Inc.
Decision Date1996-04-15
Product CodeKWS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION GLENOID COMPONENT 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 1996-04-15 under 510(k) number K960906. 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 FOUNDATION GLENOID COMPONENT?

FOUNDATION GLENOID COMPONENT is a medical device that received FDA 510(k) clearance on 1996-04-15. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K960906.

When did FOUNDATION GLENOID COMPONENT receive FDA 510(k) clearance?

FOUNDATION GLENOID COMPONENT received FDA 510(k) clearance on 1996-04-15, under 510(k) number K960906.

Who is the listed applicant for FOUNDATION GLENOID COMPONENT?

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 FOUNDATION GLENOID COMPONENT?

The FDA product code for FOUNDATION GLENOID COMPONENT is KWS.

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Other records listing Encore Orthopedics, 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.

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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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