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FDA 510(k)

SELECT SHOULDER COCR HUMERAL STEM COMPONENT

K-Number: K962315 · 1996-09-03

ApplicantIntermedics Orthopedics
Decision Date1996-09-03
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELECT SHOULDER COCR HUMERAL STEM COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1996-09-03 under 510(k) number K962315. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECT SHOULDER COCR HUMERAL STEM COMPONENT?

SELECT SHOULDER COCR HUMERAL STEM COMPONENT is a medical device that received FDA 510(k) clearance on 1996-09-03. The listed applicant is Intermedics Orthopedics. The 510(k) number is K962315.

When did SELECT SHOULDER COCR HUMERAL STEM COMPONENT receive FDA 510(k) clearance?

SELECT SHOULDER COCR HUMERAL STEM COMPONENT received FDA 510(k) clearance on 1996-09-03, under 510(k) number K962315.

Who is the listed applicant for SELECT SHOULDER COCR HUMERAL STEM COMPONENT?

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

What is the FDA product code for SELECT SHOULDER COCR HUMERAL STEM COMPONENT?

The FDA product code for SELECT SHOULDER COCR HUMERAL STEM COMPONENT is KWT.

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Other records listing Intermedics Orthopedics 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.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

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Related Devices (Code: KWT)

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.

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH

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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