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FDA 510(k)

Tigon Medical Knotless and Dual Javelin All-Suture Anchors

K-Number: K252596 · 2025-12-04

ApplicantTigon Medical
Decision Date2025-12-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Knotless and Dual Javelin All-Suture Anchors is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2025-12-04 under approval number K252596. 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 Knotless and Dual Javelin All-Suture Anchors?

Tigon Medical Knotless and Dual Javelin All-Suture Anchors is a medical device that received FDA 510(k) clearance on 2025-12-04. It is manufactured by Tigon Medical. The 510(k) number is K252596.

When was Tigon Medical Knotless and Dual Javelin All-Suture Anchors approved by the FDA?

Tigon Medical Knotless and Dual Javelin All-Suture Anchors received FDA 510(k) clearance on 2025-12-04, under approval number K252596.

What company makes Tigon Medical Knotless and Dual Javelin All-Suture Anchors?

Tigon Medical Knotless and Dual Javelin All-Suture Anchors is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical Knotless and Dual Javelin All-Suture Anchors?

The FDA product code for Tigon Medical Knotless and Dual Javelin All-Suture Anchors 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 NCT07491276 Efficacy of Using Knotless Barbed Suture vs N-Butyl Cyanoacrylate Glue Tissue Adhesive for Closure of Intraoral Surgical Incisions ACTIVE_NOT_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 K242529Tigon Medical All-Suture Anchors (ASA) K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE) 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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