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FDA 510(k)

BRITISH SPINAL FUSION SET

K-Number: K842698 · 1984-09-12

ApplicantDowns Surgical , Ltd.
Decision Date1984-09-12
Product CodeFZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BRITISH SPINAL FUSION SET 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 1984-09-12 under 510(k) number K842698. The device is classified under product code FZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRITISH SPINAL FUSION SET?

BRITISH SPINAL FUSION SET is a medical device that received FDA 510(k) clearance on 1984-09-12. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K842698.

When did BRITISH SPINAL FUSION SET receive FDA 510(k) clearance?

BRITISH SPINAL FUSION SET received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842698.

Who is the listed applicant for BRITISH SPINAL FUSION SET?

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 BRITISH SPINAL FUSION SET?

The FDA product code for BRITISH SPINAL FUSION SET is FZX.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: FZX)

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.

K914715PARALLELING GUIDESImplant Corp. of AmericaK871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USAK862564A.C.L. GUIDE KITAspen Laboratories, Inc.K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.

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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