Quattro GL Suture Anchor
FDA 510(k) K131325 · Cayenne Medical, Inc.
510(k) numberK131325
Submission
- Device name
- Quattro GL Suture Anchor
- Applicant
- Cayenne Medical, Inc.
Scottsdale, AZ, US - Received
- May 8, 2013
- Decision date
- August 16, 2013
- 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
Other 510(k)s with product code MBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from ZheJiang Decans Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192428 | AFX Femoral Implant with InserterMBI · Special | 10/05/2019SE |
| K180274 | Ventix Link Knotless Anchor with InserterMBI · Traditional | 03/21/2018SE |
| K172186 | BioWick X Implant with DriverMBI · Traditional | 10/16/2017SE |
| K161033 | AFX Femoral Implant With InserterMBI · Special | 08/03/2016SE |
| K151068 | SureLock W Suture AnchorMBI · Traditional | 07/24/2015SE |
| K143473 | Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles…MBI · Traditional | 03/25/2015SE |
| K143392 | Quattro Bolt Tenodesis ScrewMBI · Traditional | 01/23/2015SE |
| K132867 | Surelock All-Suture Anchor with Inserter, 1.4MM, Surelock All-Suture Anchor with…MBI · Traditional | 12/30/2013SE |
| K122314 | Quatro Link Knotless Anchor with Inserter, 2.9MM-PEEK OnlyMBI · Traditional | 10/31/2012SE |
| K122463 | Aperfix Am Femoral Implant with Inserter, 9X24 Aperfix Am Femoral Implant with Inserter…MBI · Special | 10/11/2012SE |
Questions and answers
When was Quattro GL Suture Anchor cleared by the FDA?
Quattro GL Suture Anchor (K131325) received a 510(k) decision of Substantially Equivalent on August 16, 2013, 100 days after the submission was received.
What is the product code of K131325?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.