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FDA 510(k)

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE

K-Number: K121323 · 2012-07-18

ApplicantMedicrea International
Decision Date2012-07-18
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2012-07-18 under 510(k) number K121323. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE?

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE is a medical device that received FDA 510(k) clearance on 2012-07-18. The listed applicant is Medicrea International. The 510(k) number is K121323.

When did MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE receive FDA 510(k) clearance?

MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE received FDA 510(k) clearance on 2012-07-18, under 510(k) number K121323.

Who is the listed applicant for MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE?

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

What is the FDA product code for MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE?

The FDA product code for MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE is KWQ.

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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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