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FDA 510(k)

ORTHOALIGN PLUS SYSTEM

K-Number: K130387 · 2013-11-08

ApplicantOrthalign, Inc.
Decision Date2013-11-08
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOALIGN PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthalign, Inc.. It received FDA 510(k) clearance on 2013-11-08 under 510(k) number K130387. 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 ORTHOALIGN PLUS SYSTEM?

ORTHOALIGN PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-08. The listed applicant is Orthalign, Inc.. The 510(k) number is K130387.

When did ORTHOALIGN PLUS SYSTEM receive FDA 510(k) clearance?

ORTHOALIGN PLUS SYSTEM received FDA 510(k) clearance on 2013-11-08, under 510(k) number K130387.

Who is the listed applicant for ORTHOALIGN PLUS SYSTEM?

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

What is the FDA product code for ORTHOALIGN PLUS SYSTEM?

The FDA product code for ORTHOALIGN PLUS SYSTEM is OLO.

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Other records listing Orthalign, Inc. as applicant

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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Related Devices (Code: 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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