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FDA 510(k)

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM

K-Number: K853033 · 1985-09-24

ApplicantA.W. Showell (Surgicraft) , Ltd.
Decision Date1985-09-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A.W. Showell (Surgicraft) , Ltd.. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853033. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM?

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is A.W. Showell (Surgicraft) , Ltd.. The 510(k) number is K853033.

When did HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853033.

Who is the listed applicant for HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM?

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

What is the FDA product code for HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM?

The FDA product code for HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM is KWQ.

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Other records listing A.W. Showell (Surgicraft) , Ltd. 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.

K844608SURGICRAFT COPELAND DISPOSABLE

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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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