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)

CEPTRE® Knotted UHMWPE Suture PEEK Anchor

K-Number: K231033 · 2024-01-04

ApplicantHealthium Medtech Limited
Decision Date2024-01-04
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Healthium Medtech Limited. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K231033. 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 CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Healthium Medtech Limited. The 510(k) number is K231033.

When did CEPTRE® Knotted UHMWPE Suture PEEK Anchor receive FDA 510(k) clearance?

CEPTRE® Knotted UHMWPE Suture PEEK Anchor received FDA 510(k) clearance on 2024-01-04, under 510(k) number K231033.

Who is the listed applicant for CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

The FDA 510(k) record lists Healthium Medtech Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor?

The FDA product code for CEPTRE® Knotted UHMWPE Suture PEEK Anchor is MBI.

Other records listing Healthium Medtech Limited 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.

K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantK232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonK231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open ButtonK223889Stativ® Knotted UHMWPE Suture Anchor

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.

↑