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FDA 510(k)

SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT

K-Number: K011985 · 2001-11-02

ApplicantSmith & Nephew, Inc.
Decision Date2001-11-02
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT 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 2001-11-02 under 510(k) number K011985. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT?

SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K011985.

When did SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT receive FDA 510(k) clearance?

SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT received FDA 510(k) clearance on 2001-11-02, under 510(k) number K011985.

Who is the listed applicant for SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT?

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 SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT?

The FDA product code for SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT is MAI.

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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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