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FDA 510(k)

TENDON STRIPPER

K-Number: K853763 · 1985-10-07

Decision Date1985-10-07
Product Code
DecisionSubstantially Equivalent

Device Summary

TENDON STRIPPER 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 1985-10-07 under 510(k) number K853763. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENDON STRIPPER?

TENDON STRIPPER is a medical device that received FDA 510(k) clearance on 1985-10-07. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K853763.

When did TENDON STRIPPER receive FDA 510(k) clearance?

TENDON STRIPPER received FDA 510(k) clearance on 1985-10-07, under 510(k) number K853763.

Who is the listed applicant for TENDON STRIPPER?

The FDA 510(k) record lists Orthopedic Systems, Inc. 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.

Other records listing Orthopedic Systems, 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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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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