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FDA 510(k)

FREE FLEX HEEL HEIGHT ADJUSTOR

K-Number: K823396 · 1982-11-29

ApplicantOrthopedic Systems, Inc.
Decision Date1982-11-29
Product CodeISH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FREE FLEX HEEL HEIGHT ADJUSTOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1982-11-29 under 510(k) number K823396. The device is classified under product code ISH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREE FLEX HEEL HEIGHT ADJUSTOR?

FREE FLEX HEEL HEIGHT ADJUSTOR is a medical device that received FDA 510(k) clearance on 1982-11-29. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K823396.

When did FREE FLEX HEEL HEIGHT ADJUSTOR receive FDA 510(k) clearance?

FREE FLEX HEEL HEIGHT ADJUSTOR received FDA 510(k) clearance on 1982-11-29, under 510(k) number K823396.

Who is the listed applicant for FREE FLEX HEEL HEIGHT ADJUSTOR?

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

What is the FDA product code for FREE FLEX HEEL HEIGHT ADJUSTOR?

The FDA product code for FREE FLEX HEEL HEIGHT ADJUSTOR is ISH.

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Other records listing Orthopedic Systems, Inc. as applicant

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Related Devices (Code: ISH)

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.

K051256SILVERSEAL ORTHOTIC COMPONENT WITH X-STATICNoble Fiber Technologies, Inc.K820505ANKLE/FOOT EXTERNALMauch Laboratories, Inc.K791331THE TUCKER-SACH FOOT AND TUCKER-SYME FTKiswood Manufacturing, 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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