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FDA 510(k)

Tigon Medical All-Suture Anchors (ASA)

K-Number: K242529 · 2024-12-20

ApplicantTigon Medical
Decision Date2024-12-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical All-Suture Anchors (ASA) is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2024-12-20 under approval number K242529. 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 Tigon Medical All-Suture Anchors (ASA)?

Tigon Medical All-Suture Anchors (ASA) is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Tigon Medical. The 510(k) number is K242529.

When was Tigon Medical All-Suture Anchors (ASA) approved by the FDA?

Tigon Medical All-Suture Anchors (ASA) received FDA 510(k) clearance on 2024-12-20, under approval number K242529.

What company makes Tigon Medical All-Suture Anchors (ASA)?

Tigon Medical All-Suture Anchors (ASA) is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical All-Suture Anchors (ASA)?

The FDA product code for Tigon Medical All-Suture Anchors (ASA) is MBI.

Related Clinical Trials

NCT07554976 Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures RECRUITING NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING NCT07498361 Comparative Analysis of fast-and Slow-absorbable Poly(Lactose-co-glycolide) Sutures in Oral Surgery: a Randomized Controlled Trial. RECRUITING NCT06636136 Transtibial Osseointegration RECRUITING

Related PubMed Literature

PMID: 40868376 Correlation Analysis of Suture Anchor Pull-Out Strength with Cortical Bone Thickness and Cancellous Bone Density on a Finite Element Model. Bioengineering (Basel, Switzerland) (2025)

Other Devices by Tigon Medical

K182507Tigon Medical Tissue Anchors K211049Tigon Medical Button System K220464Tigon Medical Gryphon Anchor Line K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE) K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors K260921Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

View all 7 devices →

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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