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FDA 510(k)

OPUS MAGNUM ANCHOR WITH INSERTER

K-Number: K041440 · 2004-06-25

ApplicantOpus Medical, Inc.
Decision Date2004-06-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPUS MAGNUM 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 2004-06-25 under 510(k) number K041440. 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 OPUS MAGNUM ANCHOR WITH INSERTER?

OPUS MAGNUM ANCHOR WITH INSERTER is a medical device that received FDA 510(k) clearance on 2004-06-25. The listed applicant is Opus Medical, Inc.. The 510(k) number is K041440.

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

OPUS MAGNUM ANCHOR WITH INSERTER received FDA 510(k) clearance on 2004-06-25, under 510(k) number K041440.

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

The FDA product code for OPUS MAGNUM ANCHOR WITH INSERTER is MBI.

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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.

K042584OPUS MINIMAGNUM ANCHOR WITH INSERTERK042914OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLEK042031OPUS SPEEDSTITCH SUTURE DEVICEK033317SMARTSTITCH 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

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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.

K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc.K262809ArthroTAK Tendon Anchor KitArthroTAK, LLCK253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc.K262677Iconix Knotless TRiverpoint MedicalK262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker Endoscopy

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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