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FDA 510(k)

UNIVERSALL DRILL GUIDE

K-Number: K820226 · 1982-02-04

ApplicantOrtho Pared Instruments, Inc.
Decision Date1982-02-04
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSALL DRILL GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pared Instruments, Inc.. It received FDA 510(k) clearance on 1982-02-04 under 510(k) number K820226. The device is classified under product code HTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSALL DRILL GUIDE?

UNIVERSALL DRILL GUIDE is a medical device that received FDA 510(k) clearance on 1982-02-04. The listed applicant is Ortho Pared Instruments, Inc.. The 510(k) number is K820226.

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

UNIVERSALL DRILL GUIDE received FDA 510(k) clearance on 1982-02-04, under 510(k) number K820226.

Who is the listed applicant for UNIVERSALL DRILL GUIDE?

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

What is the FDA product code for UNIVERSALL DRILL GUIDE?

The FDA product code for UNIVERSALL DRILL GUIDE is HTW.

Related Clinical Trials

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Other records listing Ortho Pared Instruments, 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.

K831772GUILLOTINE BLADEK820225MENISCUS EXTRACTORK812566UNIVERSAL SUTURE PASSER

Related Devices (Code: HTW)

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.

K151661Renovo Life Hard Carbon Coated Drill BitRenovo Life, LLCK942906AGEE-WRISTJACK PRE-DRILL KITHand Biomechanics Lab, Inc.K930339REAMER BITNeoligaments, Ltd.K915692CANNULATED DRILL BITW. L. Gore & Associates, Inc.K892903MITEK ANCHOR DRILLMitek Surgical Products, Inc.K870217FEMORAL CEMENT REMOVAL INSTRUMENTSKenneth J. Hoek, M.D., 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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