Cufflok Anchor
FDA 510(k) K031519 · Mitek Worldwide
510(k) numberK031519
Submission
- Device name
- Cufflok Anchor
- Applicant
- Mitek Worldwide
Norwood, MA, US - Received
- May 15, 2003
- Decision date
- June 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAI – Fastener, Fixation, Biodegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262357 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Special | Arthrex, Inc. | 08/07/2026SE |
| K253931 | Arthrex Bioabsorbable PushLock Suture AnchorsMAI · Traditional | Arthrex, Inc. | 05/28/2026SE |
| K260294 | SF Push-in AnchorMAI · Traditional | Surgical Fusion Technologies GmbH | 03/27/2026SE |
| K254055 | OSSIOfiber® Suture AnchorMAI · Traditional | OSSIO , Ltd. | 02/24/2026SE |
| K251680 | Biosteon® ScrewMAI · Traditional | Biocomposites, Ltd. | 02/17/2026SE |
| K252946 | BioBrace® Extra-Articular Ligament Augmentation KitMAI · Special | Conmed Corporation | 10/15/2025SE |
| K252022 | OSSIOfiber® Interference ScrewMAI · Traditional | OSSIO , Ltd. | 08/19/2025SE |
| K251309 | OSSIOfiber® Suture AnchorMAI · Special | OSSIO , Ltd. | 05/27/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | Stryker Endoscopy | 05/23/2025SE |
| K250528 | Stryker AlphaVent Knotless SP Biocomposite AnchorMAI · Traditional | Stryker Endoscopy | 05/21/2025SE |
More from Stryker Endoscopy
| 510(k) | Device | Decision |
|---|---|---|
| K032717 | Biocryl Rapide Interference ScrewHWC · Traditional | 03/31/2004SE |
| K032167 | Bio-Intrafix Tibial Screw and SheathHWC · Traditional | 10/15/2003SE |
| K032078 | Mitek Micro QuickanchorNOV · Traditional | 08/25/2003SE |
| K030995 | Minilok Quickanchor PlusHWC · Traditional | 06/26/2003SE |
| K031406 | Exojet Tissue Management SystemHRX · Traditional | 05/30/2003SE |
| K024115 | Microfix Quickanchor PlusHWC · Traditional | 03/13/2003SE |
| K023388 | Mitek Rapidloc-Pds Meniscal Repair SystemJDR · Special | 12/27/2002SE |
| K021953 | Mitek Pds/Pga StapleJDR · Traditional | 12/20/2002SE |
| K021883 | Biofastin RC Threaded Suture AnchorHWC · Special | 07/01/2002SE |
Questions and answers
When was Cufflok Anchor cleared by the FDA?
Cufflok Anchor (K031519) received a 510(k) decision of Substantially Equivalent on June 6, 2003, 22 days after the submission was received.
What is the product code of K031519?
The FDA product code is MAI – Fastener, Fixation, Biodegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3030.