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FDA 510(k)

BENDINI(TM) SPINAL ROD BENDING SYSTEM

K-Number: K111811 · 2011-12-05

ApplicantNuvasive, Inc.
Decision Date2011-12-05
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BENDINI(TM) SPINAL ROD BENDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2011-12-05 under 510(k) number K111811. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENDINI(TM) SPINAL ROD BENDING SYSTEM?

BENDINI(TM) SPINAL ROD BENDING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-12-05. The listed applicant is Nuvasive, Inc.. The 510(k) number is K111811.

When did BENDINI(TM) SPINAL ROD BENDING SYSTEM receive FDA 510(k) clearance?

BENDINI(TM) SPINAL ROD BENDING SYSTEM received FDA 510(k) clearance on 2011-12-05, under 510(k) number K111811.

Who is the listed applicant for BENDINI(TM) SPINAL ROD BENDING SYSTEM?

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

What is the FDA product code for BENDINI(TM) SPINAL ROD BENDING SYSTEM?

The FDA product code for BENDINI(TM) SPINAL ROD BENDING SYSTEM is OLO.

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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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