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FDA 510(k)

BLUE ORTHOCORD SUTURE

K-Number: K043298 · 2004-12-10

ApplicantDepuy Mitek
Decision Date2004-12-10
Product CodeNEW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUE ORTHOCORD SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K043298. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUE ORTHOCORD SUTURE?

BLUE ORTHOCORD SUTURE is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Depuy Mitek. The 510(k) number is K043298.

When did BLUE ORTHOCORD SUTURE receive FDA 510(k) clearance?

BLUE ORTHOCORD SUTURE received FDA 510(k) clearance on 2004-12-10, under 510(k) number K043298.

Who is the listed applicant for BLUE ORTHOCORD SUTURE?

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 BLUE ORTHOCORD SUTURE?

The FDA product code for BLUE ORTHOCORD SUTURE is NEW.

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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: NEW)

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.

K254238MINT MONO SuturesHans Biomed CorporationK253879MONOFIX PDOSamyang Holdings CorporationK261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLCK252171Barbed PDO SutureSutura Medical Technology, Inc.K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc.K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical SutureETHICON, 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.

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