Blue Orthocord Suture
FDA 510(k) K043298 · Depuy Mitek
510(k) numberK043298
Submission
- Device name
- Blue Orthocord Suture
- Applicant
- Depuy Mitek
Norwood, MA, US - Received
- November 30, 2004
- Decision date
- December 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEW – Suture, Surgical, Absorbable, Polydioxanone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4840
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K250977 | Suture-TOOL SystemNEW · Special | Suturion AB | 04/28/2025SE |
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| K080918 | Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet…NEW · Special | 04/23/2008SE |
| K060664 | Fastin RC AnchorHWC · Traditional | 06/06/2006SE |
| K041117 | Panalok RC Quickanchor Plus, Model 212130, 212730; Dual Suture Panalok RC Quickanchor…JDR · Special | 05/28/2004SE |
Questions and answers
When was Blue Orthocord Suture cleared by the FDA?
Blue Orthocord Suture (K043298) received a 510(k) decision of Substantially Equivalent on December 10, 2004, 10 days after the submission was received.
What is the product code of K043298?
The FDA product code is NEW – Suture, Surgical, Absorbable, Polydioxanone, a Class II (moderate risk) device regulated under 21 CFR 878.4840.