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FDA 510(k)

ORION ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K973854 · 1998-03-16

ApplicantSofamor Danek USA,Inc.
Decision Date1998-03-16
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ORION ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1998-03-16 under 510(k) number K973854. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ORION ANTERIOR CERVICAL PLATE SYSTEM?

ORION ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-16. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K973854.

When did ORION ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

ORION ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 1998-03-16, under 510(k) number K973854.

Who is the listed applicant for ORION ANTERIOR CERVICAL PLATE SYSTEM?

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

What is the FDA product code for ORION ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for ORION ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

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Other records listing Sofamor Danek USA,Inc. as applicant

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Related Devices (Code: KWQ)

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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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