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FDA 510(k)

MITEK ANCHOR

K-Number: K892126 · 1989-09-19

ApplicantMitek Surgical Products, Inc.
Decision Date1989-09-19
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK ANCHOR 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 1989-09-19 under 510(k) number K892126. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK ANCHOR?

MITEK ANCHOR is a medical device that received FDA 510(k) clearance on 1989-09-19. The listed applicant is Mitek Surgical Products, Inc.. The 510(k) number is K892126.

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

MITEK ANCHOR received FDA 510(k) clearance on 1989-09-19, under 510(k) number K892126.

Who is the listed applicant for MITEK ANCHOR?

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?

The FDA product code for MITEK ANCHOR is JDR.

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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: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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