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FDA 510(k)

STRYKER WEDGE SUTURE ANCHOR SYSTEM

K-Number: K041310 · 2004-06-14

ApplicantStryker Endoscopy
Decision Date2004-06-14
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER WEDGE SUTURE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2004-06-14 under 510(k) number K041310. 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 STRYKER WEDGE SUTURE ANCHOR SYSTEM?

STRYKER WEDGE SUTURE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-14. The listed applicant is Stryker Endoscopy. The 510(k) number is K041310.

When did STRYKER WEDGE SUTURE ANCHOR SYSTEM receive FDA 510(k) clearance?

STRYKER WEDGE SUTURE ANCHOR SYSTEM received FDA 510(k) clearance on 2004-06-14, under 510(k) number K041310.

Who is the listed applicant for STRYKER WEDGE SUTURE ANCHOR SYSTEM?

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

What is the FDA product code for STRYKER WEDGE SUTURE ANCHOR SYSTEM?

The FDA product code for STRYKER WEDGE SUTURE ANCHOR SYSTEM is MBI.

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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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