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FDA 510(k)

BASILDON-GARDNER SPINAL FRAME

K-Number: K842700 · 1984-09-12

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

Device Summary

BASILDON-GARDNER SPINAL FRAME 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 K842700. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASILDON-GARDNER SPINAL FRAME?

BASILDON-GARDNER SPINAL FRAME 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 K842700.

When did BASILDON-GARDNER SPINAL FRAME receive FDA 510(k) clearance?

BASILDON-GARDNER SPINAL FRAME received FDA 510(k) clearance on 1984-09-12, under 510(k) number K842700.

Who is the listed applicant for BASILDON-GARDNER SPINAL FRAME?

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 BASILDON-GARDNER SPINAL FRAME?

The FDA product code for BASILDON-GARDNER SPINAL FRAME is FWZ.

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Other records listing Downs Surgical , Ltd. as applicant

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Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, Inc.

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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