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FDA 510(k)

ROG SUTURE ANCHOR

K-Number: K113299 · 2011-12-15

ApplicantRog Sports Medicine, Inc.
Decision Date2011-12-15
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ROG SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Rog Sports Medicine, Inc.. It received FDA 510(k) clearance on 2011-12-15 under 510(k) number K113299. 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 ROG SUTURE ANCHOR?

ROG SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2011-12-15. The listed applicant is Rog Sports Medicine, Inc.. The 510(k) number is K113299.

When did ROG SUTURE ANCHOR receive FDA 510(k) clearance?

ROG SUTURE ANCHOR received FDA 510(k) clearance on 2011-12-15, under 510(k) number K113299.

Who is the listed applicant for ROG SUTURE ANCHOR?

The FDA 510(k) record lists Rog Sports Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROG SUTURE ANCHOR?

The FDA product code for ROG SUTURE ANCHOR is MBI.

Related Clinical Trials

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.

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Other records listing Rog Sports Medicine, Inc. 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.

K112991MODIFIED ROG SUTURE ANCHORK111590ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHORK110230ROG KNOTLESS SUTURE ANCHORK110229ROG SUTURE ANCHOR 5.5MM, 2.9MM

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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