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FDA 510(k)

PASS LP SPINAL

K-Number: K112736 · 2012-02-01

ApplicantMedicrea International
Decision Date2012-02-01
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASS LP SPINAL is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International. It received FDA 510(k) clearance on 2012-02-01 under 510(k) number K112736. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASS LP SPINAL?

PASS LP SPINAL is a medical device that received FDA 510(k) clearance on 2012-02-01. The listed applicant is Medicrea International. The 510(k) number is K112736.

When did PASS LP SPINAL receive FDA 510(k) clearance?

PASS LP SPINAL received FDA 510(k) clearance on 2012-02-01, under 510(k) number K112736.

Who is the listed applicant for PASS LP SPINAL?

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 PASS LP SPINAL?

The FDA product code for PASS LP SPINAL is JDQ.

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Other records listing Medicrea International as applicant

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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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