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)

OPUS MINIMAGNUM ANCHOR WITH INSERTER

K-Number: K042584 · 2004-12-14

ApplicantOpus Medical, Inc.
Decision Date2004-12-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPUS MINIMAGNUM ANCHOR WITH INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Opus Medical, Inc.. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K042584. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPUS MINIMAGNUM ANCHOR WITH INSERTER?

OPUS MINIMAGNUM ANCHOR WITH INSERTER is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Opus Medical, Inc.. The 510(k) number is K042584.

When did OPUS MINIMAGNUM ANCHOR WITH INSERTER receive FDA 510(k) clearance?

OPUS MINIMAGNUM ANCHOR WITH INSERTER received FDA 510(k) clearance on 2004-12-14, under 510(k) number K042584.

Who is the listed applicant for OPUS MINIMAGNUM ANCHOR WITH INSERTER?

The FDA 510(k) record lists Opus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPUS MINIMAGNUM ANCHOR WITH INSERTER?

The FDA product code for OPUS MINIMAGNUM ANCHOR WITH INSERTER is HWC. This falls under the Cardiovascular category.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Opus Medical, Inc. 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.

K042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042031OPUS SPEEDSTITCH SUTURE DEVICEK041440OPUS MAGNUM ANCHOR WITH INSERTERK033317SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070K030170REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500K031083OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500

View all 13 devices →

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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.

↑