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FDA 510(k)

SHEPPERD LUMBAR DISCECTOMY SYSTEM

K-Number: K900608 · 1990-10-22

ApplicantDowns Surgical , Ltd.
Decision Date1990-10-22
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHEPPERD LUMBAR DISCECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K900608. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEPPERD LUMBAR DISCECTOMY SYSTEM?

SHEPPERD LUMBAR DISCECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K900608.

When did SHEPPERD LUMBAR DISCECTOMY SYSTEM receive FDA 510(k) clearance?

SHEPPERD LUMBAR DISCECTOMY SYSTEM received FDA 510(k) clearance on 1990-10-22, under 510(k) number K900608.

Who is the listed applicant for SHEPPERD LUMBAR DISCECTOMY SYSTEM?

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

What is the FDA product code for SHEPPERD LUMBAR DISCECTOMY SYSTEM?

The FDA product code for SHEPPERD LUMBAR DISCECTOMY SYSTEM is HRX.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: HRX)

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

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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