Parcus SLiK Anchors
FDA 510(k) K170327 · Parcus Medical
510(k) numberK170327
Submission
- Device name
- Parcus SLiK Anchors
- Applicant
- Parcus Medical
Sarasota, FL, US - Received
- February 2, 2017
- Decision date
- March 30, 2017
- 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 |
|---|---|---|
| K232513 | X-Twist Biocomposite Suture AnchorMAI · Special | 09/18/2023SE |
| K221502 | Parcus Synd-EZ SSMBI · Traditional | 07/26/2022SE |
| K221135 | X-Twist PEEK Suture AnchorMBI · Special | 05/19/2022SE |
| K212739 | ActiFlipMBI · Traditional | 10/06/2021SE |
| K202662 | Parcus Titanium Interference ScrewsMBI · Traditional | 02/22/2021SE |
| K202259 | Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti…MBI · Traditional | 10/28/2020SE |
| K201083 | Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsMBI · Traditional | 07/23/2020SE |
| K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorMBI · Special | 01/23/2020SE |
| K192750 | AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate HipMBI · Traditional | 01/16/2020SE |
| K192964 | Parcus Synd-EZ SSMBI · Special | 11/22/2019SE |
Questions and answers
When was Parcus SLiK Anchors cleared by the FDA?
Parcus SLiK Anchors (K170327) received a 510(k) decision of Substantially Equivalent on March 30, 2017, 56 days after the submission was received.
What is the product code of K170327?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.