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FDA 510(k)

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS

K-Number: K970567 · 1997-02-27

ApplicantIntermedics Orthopedics
Decision Date1997-02-27
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1997-02-27 under 510(k) number K970567. 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 CURVED-BACK PEGGED ALL POLY GLENOIDS?

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS is a medical device that received FDA 510(k) clearance on 1997-02-27. The listed applicant is Intermedics Orthopedics. The 510(k) number is K970567.

When did SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS receive FDA 510(k) clearance?

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS received FDA 510(k) clearance on 1997-02-27, under 510(k) number K970567.

Who is the listed applicant for SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS?

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 CURVED-BACK PEGGED ALL POLY GLENOIDS?

The FDA product code for SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS is KWT.

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Related Devices (Code: KWT)

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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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