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FDA 510(k)

ANDREWS REMOTE CHUCK DRILL

K-Number: K831043 · 1983-04-28

ApplicantOrthopedic Systems, Inc.
Decision Date1983-04-28
Product CodeHXY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANDREWS REMOTE CHUCK DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K831043. 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 ANDREWS REMOTE CHUCK DRILL?

ANDREWS REMOTE CHUCK DRILL is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K831043.

When did ANDREWS REMOTE CHUCK DRILL receive FDA 510(k) clearance?

ANDREWS REMOTE CHUCK DRILL received FDA 510(k) clearance on 1983-04-28, under 510(k) number K831043.

Who is the listed applicant for ANDREWS REMOTE CHUCK DRILL?

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

What is the FDA product code for ANDREWS REMOTE CHUCK DRILL?

The FDA product code for ANDREWS REMOTE CHUCK DRILL is HXY.

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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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.

K923776BENDEREV DRILL GUIDENeimark Labs, Inc.K892904MITEK DRILL GUIDEMitek Surgical Products, Inc.K880264BONE SUTURE FIXATION DEVICEOrthopedic Systems, Inc.K880381TELOS DISTAL TARGETING DEVICEAustin Assoc.K880046HASTING FINGER FIXATOR INSTRUMENTSBuckman Co., Inc.K770204CEMENT EXTRACTOR DRILLDepuy, 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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