FDA 510(k)

SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..

K-Number: K111390 · 2011-09-12

Decision Date2011-09-12

Product CodeNHA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. is the device name listed in this FDA 510(k) record. The listed applicant is Cendres & Metaux SA. It received FDA 510(k) clearance on 2011-09-12 under 510(k) number K111390. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..?

SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. is a medical device that received FDA 510(k) clearance on 2011-09-12. The listed applicant is Cendres & Metaux SA. The 510(k) number is K111390.

When did SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. receive FDA 510(k) clearance?

SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. received FDA 510(k) clearance on 2011-09-12, under 510(k) number K111390.

Who is the listed applicant for SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..?

The FDA 510(k) record lists Cendres & Metaux SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA..?

The FDA product code for SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, SFI-BAR (R) IMPLANT ADAPTER STRA.. is NHA.

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Other records listing Cendres & Metaux SA 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.