QBO
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Instruments Designed For Press-Fit Osteochondral Implants
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4505
- Medical specialty
- Orthopedic
- FDA definition
- The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.
- Adverse events (MAUDE)
- 2023: 41 · 2024: 22 · 2026: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cartiva SCI instrumentation set (K192156) | Cartiva, Inc. | 2019-09-04 |
| Cartiva SCI Disposable Instrumentation Set (K181348) | Cartiva, Inc. | 2018-06-20 |
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Every clearance here is in the API, with alerts when new ones post.