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FDA 510(k)

V.E.P. HIP -VARIABLE ENDO-PROSTHESIS

K-Number: K850928 · 1985-05-28

ApplicantUnitas Ent.
Decision Date1985-05-28
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

V.E.P. HIP -VARIABLE ENDO-PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Unitas Ent.. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K850928. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the V.E.P. HIP -VARIABLE ENDO-PROSTHESIS?

V.E.P. HIP -VARIABLE ENDO-PROSTHESIS is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Unitas Ent.. The 510(k) number is K850928.

When did V.E.P. HIP -VARIABLE ENDO-PROSTHESIS receive FDA 510(k) clearance?

V.E.P. HIP -VARIABLE ENDO-PROSTHESIS received FDA 510(k) clearance on 1985-05-28, under 510(k) number K850928.

Who is the listed applicant for V.E.P. HIP -VARIABLE ENDO-PROSTHESIS?

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

What is the FDA product code for V.E.P. HIP -VARIABLE ENDO-PROSTHESIS?

The FDA product code for V.E.P. HIP -VARIABLE ENDO-PROSTHESIS is KWL.

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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

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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