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FDA 510(k)

MITEK MODULAR DRILL BIT

K-Number: K935225 · 1994-04-07

ApplicantMitek Surgical Products, Inc.
Decision Date1994-04-07
Product CodeGFG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MITEK MODULAR DRILL BIT 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 1994-04-07 under 510(k) number K935225. The device is classified under product code GFG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK MODULAR DRILL BIT?

MITEK MODULAR DRILL BIT is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K935225.

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

MITEK MODULAR DRILL BIT received FDA 510(k) clearance on 1994-04-07, under 510(k) number K935225.

Who is the listed applicant for MITEK MODULAR DRILL BIT?

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 MODULAR DRILL BIT?

The FDA product code for MITEK MODULAR DRILL BIT is GFG.

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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: GFG)

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.

K821486MICRO DRILLSSpire Medical, Inc.K821127KEY DRILLKey Medical, 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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