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FDA 510(k)

HALL DUNBAR DRILL GUIDE SYSTEM

K-Number: K864163 · 1986-11-20

ApplicantHall Surgical, Division of Zimmer, Inc.
Decision Date1986-11-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HALL DUNBAR DRILL GUIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hall Surgical, Division of Zimmer, Inc.. It received FDA 510(k) clearance on 1986-11-20 under 510(k) number K864163. 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 HALL DUNBAR DRILL GUIDE SYSTEM?

HALL DUNBAR DRILL GUIDE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is Hall Surgical, Division of Zimmer, Inc.. The 510(k) number is K864163.

When did HALL DUNBAR DRILL GUIDE SYSTEM receive FDA 510(k) clearance?

HALL DUNBAR DRILL GUIDE SYSTEM received FDA 510(k) clearance on 1986-11-20, under 510(k) number K864163.

Who is the listed applicant for HALL DUNBAR DRILL GUIDE SYSTEM?

The FDA 510(k) record lists Hall Surgical, Division of Zimmer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALL DUNBAR DRILL GUIDE SYSTEM?

The FDA product code for HALL DUNBAR DRILL GUIDE SYSTEM is HRX.

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Other records listing Hall Surgical, Division of Zimmer, Inc. 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.

K942660HALL MICROCHOICE ELECTRIC POWERED SYSTEMK864734HALL ORAL IMPLANT SYSTEMK864929HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYSTK862778HALL CANNLULA SYSTEMK862474HALL STERNUM SAWK862529HALL STERILE BUR

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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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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