Paradigm All-Suture Anchor 1.8mm, White/Black #2
FDA 510(k) K190333 · Conmed Corporation
510(k) numberK190333
Submission
- Device name
- Paradigm All-Suture Anchor 1.8mm, White/Black #2
- Applicant
- Conmed Corporation
Utica, NY, US - Received
- February 14, 2019
- Decision date
- March 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K251530 | CONMED Argo Knotless® AnchorMBI · Special | 06/18/2025SE |
| K250395 | BioBrace ® RC Delivery SystemORQ · Traditional | 04/07/2025SE |
| K244025 | Argo Knotless GENESYS AnchorMBI · Special | 01/28/2025SE |
| K242187 | BioBrace®OWW · Traditional | 11/27/2024SE |
| K240127 | PlumeSafe X5 Smoke Management SystemFYD · Traditional | 08/05/2024SE |
| K241906 | BioBrace® Reinforced ImplantOWW · Special | 07/29/2024SE |
| K240090 | Argo Knotless GENESYS AnchorMAI · Traditional | 03/05/2024SE |
Questions and answers
When was Paradigm All-Suture Anchor 1.8mm, White/Black #2 cleared by the FDA?
Paradigm All-Suture Anchor 1.8mm, White/Black #2 (K190333) received a 510(k) decision of Substantially Equivalent on March 18, 2019, 32 days after the submission was received.
What is the product code of K190333?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.