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FDA 510(k)

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES

K-Number: K083240 · 2009-01-12

ApplicantArthrocare Corp.
Decision Date2009-01-12
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2009-01-12 under 510(k) number K083240. 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 MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES?

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2009-01-12. The listed applicant is Arthrocare Corp.. The 510(k) number is K083240.

When did OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES receive FDA 510(k) clearance?

OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES received FDA 510(k) clearance on 2009-01-12, under 510(k) number K083240.

Who is the listed applicant for OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES?

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

What is the FDA product code for OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES?

The FDA product code for OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES is MBI.

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Other records listing Arthrocare Corp. as applicant

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K153186Adjustable Fixation DeviceK131709SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENTK130196SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER OBTURATOR & SHARP TIPPED OBTURATOR, LOW PROFILE DRK111399SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75K111397TITAN TI SUTURE ANCHOR SYSTEMK1107815.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES, EXTRACTION TOOL, 5.5 / 6.5MM PUNCH TAP

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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.

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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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