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FDA 510(k)

ORTHOMAP 3D 1.1 MODULE

K-Number: K093206 · 2010-08-04

ApplicantStryker Corp.
Decision Date2010-08-04
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORTHOMAP 3D 1.1 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2010-08-04 under 510(k) number K093206. 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 ORTHOMAP 3D 1.1 MODULE?

ORTHOMAP 3D 1.1 MODULE is a medical device that received FDA 510(k) clearance on 2010-08-04. The listed applicant is Stryker Corp.. The 510(k) number is K093206.

When did ORTHOMAP 3D 1.1 MODULE receive FDA 510(k) clearance?

ORTHOMAP 3D 1.1 MODULE received FDA 510(k) clearance on 2010-08-04, under 510(k) number K093206.

Who is the listed applicant for ORTHOMAP 3D 1.1 MODULE?

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

What is the FDA product code for ORTHOMAP 3D 1.1 MODULE?

The FDA product code for ORTHOMAP 3D 1.1 MODULE 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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