MBI — Fastener, Fixation, Nondegradable, Soft Tissue Class II
FDA Device Classification
Classification Details
- Product Code
- MBI
- Device Class
- Class II
- Regulation Number
- 888.3040
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K253130 | zhejiang decans medical devices co | Dione PEEK Screw System | May 27, 2026 |
| K261363 | conmed corporation | Y-Knotless Flex Anchors | May 13, 2026 |
| K253027 | ortobio | Anchor with Fiber Wire and Disposable Inserter | May 6, 2026 |
| K252635 | arthrotak | ArthroTAK Tendon Anchor Kit | May 1, 2026 |
| K260921 | tigon medical | Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line | April 21, 2026 |
| K260561 | arthrex | Arthrex FiberTak Suture Anchor | March 20, 2026 |
| K253886 | paragon 28 | Grappler Suture Anchor PCFD Tether System | March 17, 2026 |
| K254176 | baat medical products | SINEFIX | March 16, 2026 |
| K251750 | trax surgical | Trax EX Anchor | March 12, 2026 |
| K253693 | riverpoint medical | Strut Suture; No-Tie Button | March 11, 2026 |
| K260405 | arthrex | FiberTape Button | March 9, 2026 |
| K253538 | theramicro | TeKBrace Knotless Anchor | March 6, 2026 |
| K254306 | aevumed | Aevumed FENIX Suture Anchor | March 4, 2026 |
| K254229 | arthrex | Arthrex Nano FiberTak Suture Anchor | March 2, 2026 |
| K253695 | riverpoint medical | LigaMend | February 27, 2026 |
| K253763 | conmed corporation | Y-Knotless Flex Anchors | January 29, 2026 |
| K260004 | aevumed | Aevumed PROTEKT Suture Anchor | January 28, 2026 |
| K253618 | abanza tecnomed s.l | QuadLock Fixation System | January 6, 2026 |
| K253895 | arthrex | Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm | December 30, 2025 |
| K252596 | tigon medical | Tigon Medical Knotless and Dual Javelin All-Suture Anchors | December 4, 2025 |