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FDA 510(k)

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE

K-Number: K984530 · 1999-08-10

ApplicantMetrika, Inc.
Decision Date1999-08-10
Product CodeJFY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE is the device name listed in this FDA 510(k) record. The listed applicant is Metrika, Inc.. It received FDA 510(k) clearance on 1999-08-10 under 510(k) number K984530. The device is classified under product code JFY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE?

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE is a medical device that received FDA 510(k) clearance on 1999-08-10. The listed applicant is Metrika, Inc.. The 510(k) number is K984530.

When did DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE receive FDA 510(k) clearance?

DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE received FDA 510(k) clearance on 1999-08-10, under 510(k) number K984530.

Who is the listed applicant for DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE?

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

What is the FDA product code for DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE?

The FDA product code for DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE is JFY.

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Other records listing Metrika, Inc. as applicant

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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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