FDA 510(k)

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT

K-Number: K964616 · 1997-08-07

Decision Date1997-08-07

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Whiteside Biomechanics, Inc.. It received FDA 510(k) clearance on 1997-08-07 under 510(k) number K964616. 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 QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT?

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1997-08-07. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K964616.

When did QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT receive FDA 510(k) clearance?

QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT received FDA 510(k) clearance on 1997-08-07, under 510(k) number K964616.

Who is the listed applicant for QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT?

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

What is the FDA product code for QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT?

The FDA product code for QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT is LPH.

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Other records listing Whiteside Biomechanics, Inc. as applicant

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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.