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FDA 510(k)

CORING NEEDLE (TREPHINE, ORTHOPEDIC)

K-Number: K902447 · 1990-08-14

ApplicantBiomedtrix, Ltd.
Decision Date1990-08-14
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CORING NEEDLE (TREPHINE, ORTHOPEDIC) is the device name listed in this FDA 510(k) record. The listed applicant is Biomedtrix, Ltd.. It received FDA 510(k) clearance on 1990-08-14 under 510(k) number K902447. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORING NEEDLE (TREPHINE, ORTHOPEDIC)?

CORING NEEDLE (TREPHINE, ORTHOPEDIC) is a medical device that received FDA 510(k) clearance on 1990-08-14. The listed applicant is Biomedtrix, Ltd.. The 510(k) number is K902447.

When did CORING NEEDLE (TREPHINE, ORTHOPEDIC) receive FDA 510(k) clearance?

CORING NEEDLE (TREPHINE, ORTHOPEDIC) received FDA 510(k) clearance on 1990-08-14, under 510(k) number K902447.

Who is the listed applicant for CORING NEEDLE (TREPHINE, ORTHOPEDIC)?

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

What is the FDA product code for CORING NEEDLE (TREPHINE, ORTHOPEDIC)?

The FDA product code for CORING NEEDLE (TREPHINE, ORTHOPEDIC) is HWE.

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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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