SECULOK Suture Anchor
FDA 510(k) K180759 · U&I Corporation
510(k) numberK180759
Submission
- Device name
- SECULOK Suture Anchor
- Applicant
- U&I Corporation
Uijeongbu-Si, KR - Received
- March 22, 2018
- Decision date
- August 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
| K262809 | ArthroTAK Tendon Anchor KitMBI · Special | ArthroTAK, LLC | 09/02/2026SE |
| K253065 | Aevumed SUPERCYNCH Button SystemMBI · Traditional | Aevumed, Inc. | 09/02/2026SE |
| K262677 | Iconix Knotless TMBI · Special | Riverpoint Medical | 08/27/2026SE |
| K262047 | Grappler Suture Anchor SystemMBI · Special | Paragon 28, Inc. | 08/03/2026SE |
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair…MBI · Special | Stryker Endoscopy | 07/30/2026SE |
| K261770 | Suture Button Repair SystemMBI · Traditional | Skeletal Dynamics, Inc. | 07/29/2026SE |
| K261632 | Thunderbolt SystemMBI · Special | Responsive Arthroscopy, Inc. | 07/20/2026SE |
| K261968 | Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE…MBI · Special | Smith & Nephew, Inc. | 07/09/2026SE |
| K260018 | Arthrex FiberButtonMBI · Traditional | Arthrex, Inc. | 06/26/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/27/2026SE |
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| K220147 | Aspiron S ACP SystemKWQ · Special | 02/16/2022SE |
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| K183243 | Velofix TLIF CageMAX · Special | 07/10/2019SE |
| K190067 | Velofix Interbody Fusion SystemODP · Special | 02/04/2019SE |
| K190053 | SECULOK ACP SystemKWQ · Special | 02/01/2019SE |
| K181824 | CBT Screw Fixation SystemNKB · Traditional | 12/13/2018SE |
| K183383 | ANAX OCT Spinal SystemNKG · Special | 12/12/2018SE |
| K181829 | Velofix TLIF CageMAX · Special | 11/14/2018SE |
| K182055 | SECULOK ACP SystemKWQ · Traditional | 09/10/2018SE |
| K173198 | Facet Screw Fixation SystemMRW · Traditional | 01/03/2018SE |
Questions and answers
When was SECULOK Suture Anchor cleared by the FDA?
SECULOK Suture Anchor (K180759) received a 510(k) decision of Substantially Equivalent on August 9, 2018, 140 days after the submission was received.
What is the product code of K180759?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.