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FDA 510(k)

OSTEO-MESH TM-300

K-Number: K984230 · 1999-02-04

ApplicantOsteogenics Biomedical, Inc.
Decision Date1999-02-04
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEO-MESH TM-300 is the device name listed in this FDA 510(k) record. The listed applicant is Osteogenics Biomedical, Inc.. It received FDA 510(k) clearance on 1999-02-04 under 510(k) number K984230. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO-MESH TM-300?

OSTEO-MESH TM-300 is a medical device that received FDA 510(k) clearance on 1999-02-04. The listed applicant is Osteogenics Biomedical, Inc.. The 510(k) number is K984230.

When did OSTEO-MESH TM-300 receive FDA 510(k) clearance?

OSTEO-MESH TM-300 received FDA 510(k) clearance on 1999-02-04, under 510(k) number K984230.

Who is the listed applicant for OSTEO-MESH TM-300?

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

What is the FDA product code for OSTEO-MESH TM-300?

The FDA product code for OSTEO-MESH TM-300 is JEY.

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Related Devices (Code: JEY)

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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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