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FDA 510(k)

MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM

K-Number: K990515 · 1999-05-13

ApplicantInternational Medical Systems
Decision Date1999-05-13
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Medical Systems. It received FDA 510(k) clearance on 1999-05-13 under 510(k) number K990515. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM?

MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-13. The listed applicant is International Medical Systems. The 510(k) number is K990515.

When did MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM receive FDA 510(k) clearance?

MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM received FDA 510(k) clearance on 1999-05-13, under 510(k) number K990515.

Who is the listed applicant for MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM?

The FDA 510(k) record lists International Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM?

The FDA product code for MATHIS VERTEBRAL AND BONE BIOPSY SYSTEM is KNW.

Related Clinical Trials

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.

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Other records listing International Medical Systems 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.

K946039MODEL #5000 PULMO PLUS

Related Devices (Code: KNW)

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.

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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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