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FDA 510(k)

FLEXISTAND MAJOR

K-Number: K852152 · 1985-11-05

Decision Date1985-11-05
Product Code
DecisionSubstantially Equivalent

Device Summary

FLEXISTAND MAJOR is the device name listed in this FDA 510(k) record. The listed applicant is Zygotek Assoc.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K852152. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXISTAND MAJOR?

FLEXISTAND MAJOR is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Zygotek Assoc.. The 510(k) number is K852152.

When did FLEXISTAND MAJOR receive FDA 510(k) clearance?

FLEXISTAND MAJOR received FDA 510(k) clearance on 1985-11-05, under 510(k) number K852152.

Who is the listed applicant for FLEXISTAND MAJOR?

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

Related Clinical Trials

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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