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FDA 510(k)

STRAIGHT STEM FEMORAL HEAD PROSTHESIS

K-Number: K831851 · 1983-10-06

ApplicantProteck, Inc.
Decision Date1983-10-06
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRAIGHT STEM FEMORAL HEAD PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Proteck, Inc.. It received FDA 510(k) clearance on 1983-10-06 under 510(k) number K831851. 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 STRAIGHT STEM FEMORAL HEAD PROSTHESIS?

STRAIGHT STEM FEMORAL HEAD PROSTHESIS is a medical device that received FDA 510(k) clearance on 1983-10-06. The listed applicant is Proteck, Inc.. The 510(k) number is K831851.

When did STRAIGHT STEM FEMORAL HEAD PROSTHESIS receive FDA 510(k) clearance?

STRAIGHT STEM FEMORAL HEAD PROSTHESIS received FDA 510(k) clearance on 1983-10-06, under 510(k) number K831851.

Who is the listed applicant for STRAIGHT STEM FEMORAL HEAD PROSTHESIS?

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

What is the FDA product code for STRAIGHT STEM FEMORAL HEAD PROSTHESIS?

The FDA product code for STRAIGHT STEM FEMORAL HEAD PROSTHESIS is KWL.

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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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