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FDA 510(k)

SEGMENTAL DEFECT REPLACEMENT SYSTEM

K-Number: K980609 · 1998-05-18

ApplicantMetagen, LLC
Decision Date1998-05-18
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SEGMENTAL DEFECT REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Metagen, LLC. It received FDA 510(k) clearance on 1998-05-18 under 510(k) number K980609. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEGMENTAL DEFECT REPLACEMENT SYSTEM?

SEGMENTAL DEFECT REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-18. The listed applicant is Metagen, LLC. The 510(k) number is K980609.

When did SEGMENTAL DEFECT REPLACEMENT SYSTEM receive FDA 510(k) clearance?

SEGMENTAL DEFECT REPLACEMENT SYSTEM received FDA 510(k) clearance on 1998-05-18, under 510(k) number K980609.

Who is the listed applicant for SEGMENTAL DEFECT REPLACEMENT SYSTEM?

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

What is the FDA product code for SEGMENTAL DEFECT REPLACEMENT SYSTEM?

The FDA product code for SEGMENTAL DEFECT REPLACEMENT SYSTEM is HSB.

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Other records listing Metagen, LLC 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.

K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMK980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEMK964003METAGEN ALL POLY ACETABULAR CUP SYSTEMK963700METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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