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FDA 510(k)

SPEEDFIX SUTURE SYSTEM

K-Number: K101437 · 2010-10-29

ApplicantArthrocare Corp.
Decision Date2010-10-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPEEDFIX SUTURE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K101437. 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 SPEEDFIX SUTURE SYSTEM?

SPEEDFIX SUTURE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Arthrocare Corp.. The 510(k) number is K101437.

When did SPEEDFIX SUTURE SYSTEM receive FDA 510(k) clearance?

SPEEDFIX SUTURE SYSTEM received FDA 510(k) clearance on 2010-10-29, under 510(k) number K101437.

Who is the listed applicant for SPEEDFIX SUTURE SYSTEM?

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

What is the FDA product code for SPEEDFIX SUTURE SYSTEM?

The FDA product code for SPEEDFIX SUTURE SYSTEM is MBI.

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Other records listing Arthrocare Corp. 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.

K153186Adjustable Fixation DeviceK131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENTK130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRK111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75K111397TITAN TI SUTURE ANCHOR SYSTEMK1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

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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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