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FDA 510(k)

AGEE-WRISTJACK PRE-DRILL KIT

K-Number: K942906 · 1994-12-22

ApplicantHand Biomechanics Lab, Inc.
Decision Date1994-12-22
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGEE-WRISTJACK PRE-DRILL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hand Biomechanics Lab, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K942906. 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 AGEE-WRISTJACK PRE-DRILL KIT?

AGEE-WRISTJACK PRE-DRILL KIT is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Hand Biomechanics Lab, Inc.. The 510(k) number is K942906.

When did AGEE-WRISTJACK PRE-DRILL KIT receive FDA 510(k) clearance?

AGEE-WRISTJACK PRE-DRILL KIT received FDA 510(k) clearance on 1994-12-22, under 510(k) number K942906.

Who is the listed applicant for AGEE-WRISTJACK PRE-DRILL KIT?

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

What is the FDA product code for AGEE-WRISTJACK PRE-DRILL KIT?

The FDA product code for AGEE-WRISTJACK PRE-DRILL KIT is HTW.

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Other records listing Hand Biomechanics Lab, Inc. as applicant

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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, LLCK930339REAMER BITNeoligaments, Ltd.K915692CANNULATED DRILL BITW. L. Gore & Associates, Inc.K892903MITEK ANCHOR DRILLMitek Surgical Products, Inc.K870217FEMORAL CEMENT REMOVAL INSTRUMENTSKenneth J. Hoek, M.D., Inc.K863147GLENOID DRILLBowen & Company, 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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