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FDA 510(k)

SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR

K-Number: K093428 · 2009-12-17

ApplicantSmith & Nephew Endoscopy, Inc.
Decision Date2009-12-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Endoscopy, Inc.. It received FDA 510(k) clearance on 2009-12-17 under 510(k) number K093428. 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 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR?

SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR is a medical device that received FDA 510(k) clearance on 2009-12-17. The listed applicant is Smith & Nephew Endoscopy, Inc.. The 510(k) number is K093428.

When did SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR receive FDA 510(k) clearance?

SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR received FDA 510(k) clearance on 2009-12-17, under 510(k) number K093428.

Who is the listed applicant for SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR?

The FDA 510(k) record lists Smith & Nephew Endoscopy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR?

The FDA product code for SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR is MBI.

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Other records listing Smith & Nephew Endoscopy, Inc. as applicant

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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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