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FDA 510(k)

CAST WEDGE, YANCEY

K-Number: K781112 · 1978-07-17

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1978-07-17
Product Code
DecisionSubstantially Equivalent

Device Summary

CAST WEDGE, YANCEY is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K781112. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAST WEDGE, YANCEY?

CAST WEDGE, YANCEY is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K781112.

When did CAST WEDGE, YANCEY receive FDA 510(k) clearance?

CAST WEDGE, YANCEY received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781112.

Who is the listed applicant for CAST WEDGE, YANCEY?

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

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Other records listing Orthopedic Equipment Co., 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.

K834035UNIVERSAL SELF-ALIGNING ACETABULAR COMK841189OEC/REZAIAN SPINAL FIXATORK800530SCHLEIN TRI-SURFACE ANKLEK781445SPREADERK790247TOURNIQUET TEST GAGEK790209FILTER SYSTEM, ALTNER DISPOSABLE

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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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