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FDA 510(k)

WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES

K-Number: K092914 · 2009-12-09

ApplicantMedshape Solutions
Decision Date2009-12-09
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES is the device name listed in this FDA 510(k) record. The listed applicant is Medshape Solutions. It received FDA 510(k) clearance on 2009-12-09 under 510(k) number K092914. 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 WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES?

WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES is a medical device that received FDA 510(k) clearance on 2009-12-09. The listed applicant is Medshape Solutions. The 510(k) number is K092914.

When did WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES receive FDA 510(k) clearance?

WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES received FDA 510(k) clearance on 2009-12-09, under 510(k) number K092914.

Who is the listed applicant for WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES?

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

What is the FDA product code for WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES?

The FDA product code for WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES is MBI.

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Other records listing Medshape Solutions 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.

K101934DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000K101808SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNERK091202WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,K083792WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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