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FDA 510(k)

MITEK ANCHOR DRILL

K-Number: K892903 · 1989-10-06

ApplicantMitek Surgical Products, Inc.
Decision Date1989-10-06
Product CodeHTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK ANCHOR DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Surgical Products, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K892903. 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 MITEK ANCHOR DRILL?

MITEK ANCHOR DRILL is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K892903.

When did MITEK ANCHOR DRILL receive FDA 510(k) clearance?

MITEK ANCHOR DRILL received FDA 510(k) clearance on 1989-10-06, under 510(k) number K892903.

Who is the listed applicant for MITEK ANCHOR DRILL?

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

What is the FDA product code for MITEK ANCHOR DRILL?

The FDA product code for MITEK ANCHOR DRILL is HTW.

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Other records listing Mitek Surgical Products, 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.

K953560MITEK THREADED ANCHOR (FASTIN)K953877MITEK GII ANCHORK936311MITEK MINI ANCHORK941599MITEK ABSORBABLE ANCHORK944051ABSORBALBE ANCHORK950070MITEK TOGGLE ANCHOR(TM)

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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, LLCK942906AGEE-WRISTJACK PRE-DRILL KITHand Biomechanics Lab, Inc.K930339REAMER BITNeoligaments, Ltd.K915692CANNULATED DRILL BITW. L. Gore & Associates, 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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