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FDA 510(k)

Ibis® Pedicle Screw System

K-Number: K162995 · 2017-03-30

ApplicantOrtho Development Corporation
Decision Date2017-03-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Ibis® Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K162995. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ibis® Pedicle Screw System?

Ibis® Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Ortho Development Corporation. The 510(k) number is K162995.

When did Ibis® Pedicle Screw System receive FDA 510(k) clearance?

Ibis® Pedicle Screw System received FDA 510(k) clearance on 2017-03-30, under 510(k) number K162995.

Who is the listed applicant for Ibis® Pedicle Screw System?

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

What is the FDA product code for Ibis® Pedicle Screw System?

The FDA product code for Ibis® Pedicle Screw System is NKB.

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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