FDA 510(k)

PROTRACT PRESS FIT HIP STEM-HA COATED

K-Number: K010241 · 2001-02-08

Decision Date2001-02-08

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PROTRACT PRESS FIT HIP STEM-HA COATED is the device name listed in this FDA 510(k) record. The listed applicant is Stelkast Company. It received FDA 510(k) clearance on 2001-02-08 under 510(k) number K010241. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTRACT PRESS FIT HIP STEM-HA COATED?

PROTRACT PRESS FIT HIP STEM-HA COATED is a medical device that received FDA 510(k) clearance on 2001-02-08. The listed applicant is Stelkast Company. The 510(k) number is K010241.

When did PROTRACT PRESS FIT HIP STEM-HA COATED receive FDA 510(k) clearance?

PROTRACT PRESS FIT HIP STEM-HA COATED received FDA 510(k) clearance on 2001-02-08, under 510(k) number K010241.

Who is the listed applicant for PROTRACT PRESS FIT HIP STEM-HA COATED?

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

What is the FDA product code for PROTRACT PRESS FIT HIP STEM-HA COATED?

The FDA product code for PROTRACT PRESS FIT HIP STEM-HA COATED is LPH.

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Other records listing Stelkast Company as applicant

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Related Devices (Code: LPH)

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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.