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FDA 510(k)

SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06

K-Number: K021379 · 2002-05-31

ApplicantOrtho Tec, LLC
Decision Date2002-05-31
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Tec, LLC. It received FDA 510(k) clearance on 2002-05-31 under 510(k) number K021379. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06?

SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 is a medical device that received FDA 510(k) clearance on 2002-05-31. The listed applicant is Ortho Tec, LLC. The 510(k) number is K021379.

When did SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 receive FDA 510(k) clearance?

SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 received FDA 510(k) clearance on 2002-05-31, under 510(k) number K021379.

Who is the listed applicant for SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06?

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

What is the FDA product code for SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06?

The FDA product code for SCS CLARIS SPINAL SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 is MNI.

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Other records listing Ortho Tec, LLC as applicant

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Related Devices (Code: MNI)

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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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