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FDA 510(k)

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line

K-Number: K260921 · 2026-04-21

ApplicantTigon Medical
Decision Date2026-04-21
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is a medical device manufactured by Tigon Medical. It received FDA 510(k) clearance on 2026-04-21 under approval number K260921. 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 Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by Tigon Medical. The 510(k) number is K260921.

When was Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line approved by the FDA?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line received FDA 510(k) clearance on 2026-04-21, under approval number K260921.

What company makes Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is manufactured by Tigon Medical.

What is the FDA product code for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line?

The FDA product code for Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line is MBI.

Related Clinical Trials

NCT06542744 Comparison of the Flexibility of the Perineum in Primiparous Women Using the Medical Device Emagina During 90 Days of Their Pregnancy Compared to Those Having a Standard Pregnancy Follow-up ACTIVE_NOT_RECRUITING 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: 41810241 Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance. Frontiers in medicine (2026) PMID: 41738390 Evolution of AI-based software as a medical device: from static tools to adaptive clinical partners. Expert review of medical devices (2026) PMID: 41407822 Do we need prequalification of AI as a medical device to drive equitable adoption. NPJ digital medicine (2025) 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) K252596Tigon Medical Knotless and Dual Javelin All-Suture Anchors

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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