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FDA 510(k)

BIOFLEX

K-Number: K072321 · 2008-03-25

ApplicantBiospine Co., Ltd.
Decision Date2008-03-25
Product CodeNQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Biospine Co., Ltd.. It received FDA 510(k) clearance on 2008-03-25 under 510(k) number K072321. The device is classified under product code NQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFLEX?

BIOFLEX is a medical device that received FDA 510(k) clearance on 2008-03-25. The listed applicant is Biospine Co., Ltd.. The 510(k) number is K072321.

When did BIOFLEX receive FDA 510(k) clearance?

BIOFLEX received FDA 510(k) clearance on 2008-03-25, under 510(k) number K072321.

Who is the listed applicant for BIOFLEX?

The FDA 510(k) record lists Biospine Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOFLEX?

The FDA product code for BIOFLEX is NQP.

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Related Devices (Code: NQP)

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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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