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FDA 510(k)

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13

K-Number: K111779 · 2011-08-08

ApplicantConmed Linvatec
Decision Date2011-08-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Linvatec. It received FDA 510(k) clearance on 2011-08-08 under 510(k) number K111779. 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 Y-KNOT ALL-SUTURE ANCHOR MODEL HF13?

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 is a medical device that received FDA 510(k) clearance on 2011-08-08. The listed applicant is Conmed Linvatec. The 510(k) number is K111779.

When did Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 receive FDA 510(k) clearance?

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 received FDA 510(k) clearance on 2011-08-08, under 510(k) number K111779.

Who is the listed applicant for Y-KNOT ALL-SUTURE ANCHOR MODEL HF13?

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

What is the FDA product code for Y-KNOT ALL-SUTURE ANCHOR MODEL HF13?

The FDA product code for Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 is MBI.

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Other records listing Conmed Linvatec 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.

K102410MATRYX INTERFERENCE SCREW (5.0-6.5MM)K102339CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICEK101100CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503K092898CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURESK090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYSK083161ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100)

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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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