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FDA 510(k)

BIOPRO - INFINITY PLATE ANCHOR SYSTEM

K-Number: K132510 · 2013-10-24

ApplicantBiopro, Inc.
Decision Date2013-10-24
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO - INFINITY PLATE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 2013-10-24 under 510(k) number K132510. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO - INFINITY PLATE ANCHOR SYSTEM?

BIOPRO - INFINITY PLATE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2013-10-24. The listed applicant is Biopro, Inc.. The 510(k) number is K132510.

When did BIOPRO - INFINITY PLATE ANCHOR SYSTEM receive FDA 510(k) clearance?

BIOPRO - INFINITY PLATE ANCHOR SYSTEM received FDA 510(k) clearance on 2013-10-24, under 510(k) number K132510.

Who is the listed applicant for BIOPRO - INFINITY PLATE ANCHOR SYSTEM?

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

What is the FDA product code for BIOPRO - INFINITY PLATE ANCHOR SYSTEM?

The FDA product code for BIOPRO - INFINITY PLATE ANCHOR SYSTEM is HTN.

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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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