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FDA 510(k)

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE

K-Number: K042914 · 2004-11-12

ApplicantOpus Medical, Inc.
Decision Date2004-11-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE 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 2004-11-12 under 510(k) number K042914. 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 KNOTLESS ANCHOR WITH INSERTER HANDLE?

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE is a medical device that received FDA 510(k) clearance on 2004-11-12. The listed applicant is Opus Medical, Inc.. The 510(k) number is K042914.

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

OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE received FDA 510(k) clearance on 2004-11-12, under 510(k) number K042914.

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

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 KNOTLESS ANCHOR WITH INSERTER HANDLE?

The FDA product code for OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE 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 INSERTERK042031OPUS 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: 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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