FDA 510(k)

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF

K-Number: K083798 · 2010-05-19

Decision Date2010-05-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea Technologies. It received FDA 510(k) clearance on 2010-05-19 under 510(k) number K083798. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF?

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF is a medical device that received FDA 510(k) clearance on 2010-05-19. The listed applicant is Medicrea Technologies. The 510(k) number is K083798.

When did IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF receive FDA 510(k) clearance?

IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF received FDA 510(k) clearance on 2010-05-19, under 510(k) number K083798.

Who is the listed applicant for IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF?

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

What is the FDA product code for IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF?

The FDA product code for IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF is MAX.

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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.