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FDA 510(k)

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE

K-Number: K083609 · 2009-03-06

ApplicantKfx Medical
Decision Date2009-03-06
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Kfx Medical. It received FDA 510(k) clearance on 2009-03-06 under 510(k) number K083609. 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 KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE?

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE is a medical device that received FDA 510(k) clearance on 2009-03-06. The listed applicant is Kfx Medical. The 510(k) number is K083609.

When did KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE receive FDA 510(k) clearance?

KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE received FDA 510(k) clearance on 2009-03-06, under 510(k) number K083609.

Who is the listed applicant for KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE?

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

What is the FDA product code for KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE?

The FDA product code for KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE is MBI.

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Other records listing Kfx Medical 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.

K120841APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHORK101175KFX APPIANFX PEEK FEMORAL IMPLANT WITH INSERTERK081598SUTURE LOCK NAIL BONE ANCHOR WITH WHITE (KFX-W-200) & BLUE (KFX-B-200) FIBERFORCE SUTUREK0802295.5 MM SUTURE LOCK BONE SCREW ANCHORK072063KFX TISSUE FIXATION SYSTEM AND ACCESSORIESK061294KFX KNOTLESS FIXATION SYSTEM

View all 7 devices →

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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