Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)

K-Number: K231002 · 2023-06-07

ApplicantSuzhou Endophix Co., Ltd.
Decision Date2023-06-07
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K231002. 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 Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K231002.

When did Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) receive FDA 510(k) clearance?

Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) received FDA 510(k) clearance on 2023-06-07, under 510(k) number K231002.

Who is the listed applicant for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

The FDA 510(k) record lists Suzhou Endophix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless)?

The FDA product code for Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) 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.

NCT04552119Safety of Treatment of Shoulder RepairCOMPLETED

Other records listing Suzhou Endophix Co., Ltd. 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.

K232941Megaloop Button SystemK232725Javelot Ti Suture Anchor, Javelot Ti-D Suture AnchorK230874Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.

↑