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)

Infinity Fixation System

K-Number: K191204 · 2019-07-03

ApplicantConmed Corporation
Decision Date2019-07-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Infinity Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Conmed Corporation. It received FDA 510(k) clearance on 2019-07-03 under 510(k) number K191204. 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 Infinity Fixation System?

Infinity Fixation System is a medical device that received FDA 510(k) clearance on 2019-07-03. The listed applicant is Conmed Corporation. The 510(k) number is K191204.

When did Infinity Fixation System receive FDA 510(k) clearance?

Infinity Fixation System received FDA 510(k) clearance on 2019-07-03, under 510(k) number K191204.

Who is the listed applicant for Infinity Fixation System?

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

What is the FDA product code for Infinity Fixation System?

The FDA product code for Infinity Fixation System is MBI.

Other records listing Conmed Corporation 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.

K261363Y-Knotless™ Flex AnchorsK253763Y-Knotless™ Flex AnchorsK252946BioBrace® Extra-Articular Ligament Augmentation KitK251530CONMED Argo Knotless® AnchorK250395BioBrace ® RC Delivery SystemK244025Argo Knotless GENESYS Anchor

View all 48 devices →

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.

↑