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FDA 510(k)

BENDEREV DRILL GUIDE

K-Number: K923776 · 1992-11-06

ApplicantNeimark Labs, Inc.
Decision Date1992-11-06
Product CodeHXY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BENDEREV DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Neimark Labs, Inc.. It received FDA 510(k) clearance on 1992-11-06 under 510(k) number K923776. The device is classified under product code HXY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENDEREV DRILL GUIDE?

BENDEREV DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1992-11-06. The listed applicant is Neimark Labs, Inc.. The 510(k) number is K923776.

When did BENDEREV DRILL GUIDE receive FDA 510(k) clearance?

BENDEREV DRILL GUIDE received FDA 510(k) clearance on 1992-11-06, under 510(k) number K923776.

Who is the listed applicant for BENDEREV DRILL GUIDE?

The FDA 510(k) record lists Neimark Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BENDEREV DRILL GUIDE?

The FDA product code for BENDEREV DRILL GUIDE is HXY.

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Other records listing Neimark Labs, 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.

K933536CARTER-THOMASON NEEDLE-POINT SUTURE PASSER

Related Devices (Code: HXY)

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.

K892904MITEK DRILL GUIDEMitek Surgical Products, Inc.K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.K880381TELOS DISTAL TARGETING DEVICEAustin Assoc.K880046HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.K831043ANDREWS REMOTE CHUCK DRILLOrthopedic Systems, Inc.K770204CEMENT EXTRACTOR DRILLDepuy, Inc.

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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