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FDA 510(k)

MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX

K-Number: K970119 · 1998-01-30

ApplicantMitek Products
Decision Date1998-01-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 1998-01-30 under 510(k) number K970119. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX?

MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX is a medical device that received FDA 510(k) clearance on 1998-01-30. The listed applicant is Mitek Products. The 510(k) number is K970119.

When did MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX receive FDA 510(k) clearance?

MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX received FDA 510(k) clearance on 1998-01-30, under 510(k) number K970119.

Who is the listed applicant for MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX?

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

What is the FDA product code for MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX?

The FDA product code for MITEK ABSORBABLE POLYDIOXANONE (PDS) H FIX is MBI.

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Other records listing Mitek Products 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.

K013572MITEK BIOCRYL INTERFERENCE SCREWSK013781RIDIDFIX 2.7MM BTB CROSS PIN KITK002639BIOKNOTLESS ANCHORK010633RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEMK002406MITEK 2GII MENISCAL REPAIR SYSTEMK003076MITEK CUFFTACK

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Related Devices (Code: MBI)

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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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