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FDA 510(k)

BIOKNOTLESS RC ANCHOR

K-Number: K041064 · 2004-05-13

ApplicantDepuy Mitek
Decision Date2004-05-13
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOKNOTLESS RC ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2004-05-13 under 510(k) number K041064. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOKNOTLESS RC ANCHOR?

BIOKNOTLESS RC ANCHOR is a medical device that received FDA 510(k) clearance on 2004-05-13. The listed applicant is Depuy Mitek. The 510(k) number is K041064.

When did BIOKNOTLESS RC ANCHOR receive FDA 510(k) clearance?

BIOKNOTLESS RC ANCHOR received FDA 510(k) clearance on 2004-05-13, under 510(k) number K041064.

Who is the listed applicant for BIOKNOTLESS RC ANCHOR?

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

What is the FDA product code for BIOKNOTLESS RC ANCHOR?

The FDA product code for BIOKNOTLESS RC ANCHOR is JDR.

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Other records listing Depuy Mitek 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.

K243790GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorK241010HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchorsK240441MILAGRO Interference Screw; MILAGRO ADVANCE Interference ScrewK120449HEALIX ADVANCE PEEK ANCHORK080918DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0K060664FASTIN RC ANCHOR

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Related Devices (Code: JDR)

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.

K262451Arthrex DynaNite StaplesArthrex, Inc.K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical Concepts

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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