Renovo Suture Anchors, Models 100-2001 Thru 100-5502X
FDA 510(k) K071520 · Core Essence Orthopaedics, LLC
510(k) numberK071520
Submission
- Device name
- Renovo Suture Anchors, Models 100-2001 Thru 100-5502X
- Applicant
- Core Essence Orthopaedics, LLC
Yardley, PA, US - Received
- June 4, 2007
- Decision date
- August 10, 2007
- 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 |
|---|---|---|
| K111716 | Knotless Suture Fixation SystemMBI · Traditional | 11/10/2011SE |
| K101126 | Pontis Sutures and Suture Anchors with Optional CrimpsMBI · Traditional | 12/02/2010SE |
| K090128 | Tac-Tite (TM)GAT · Special | 03/19/2009SE |
| K081060 | Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (Usp) 5-0 to #5GAQ · Abbreviated | 12/24/2008SE |
| K071477 | Reverto 55 and 37 Shape Memory StaplesJDR · Traditional | 08/15/2007SE |
Questions and answers
When was Renovo Suture Anchors, Models 100-2001 Thru 100-5502X cleared by the FDA?
Renovo Suture Anchors, Models 100-2001 Thru 100-5502X (K071520) received a 510(k) decision of Substantially Equivalent on August 10, 2007, 67 days after the submission was received.
What is the product code of K071520?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.