FDA 510(k)

REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING

K-Number: K060630 · 2006-06-14

Decision Date2006-06-14

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2006-06-14 under 510(k) number K060630. 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 REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING?

REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING is a medical device that received FDA 510(k) clearance on 2006-06-14. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K060630.

When did REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING receive FDA 510(k) clearance?

REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING received FDA 510(k) clearance on 2006-06-14, under 510(k) number K060630.

Who is the listed applicant for REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING?

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

What is the FDA product code for REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING?

The FDA product code for REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING is 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.