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FDA 510(k)

NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER

K-Number: K130351 · 2013-03-14

ApplicantPivot Medical, Inc.
Decision Date2013-03-14
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Pivot Medical, Inc.. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K130351. 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 NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER?

NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Pivot Medical, Inc.. The 510(k) number is K130351.

When did NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER receive FDA 510(k) clearance?

NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER received FDA 510(k) clearance on 2013-03-14, under 510(k) number K130351.

Who is the listed applicant for NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER?

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

What is the FDA product code for NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER?

The FDA product code for NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER 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 Pivot Medical, 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.

K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM

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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