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.
| Device Type ID | 4693 |
| Device Name | Instruments Designed For Press-fit Osteochondral Implants |
| Physical State | Smooth, Metallic, With Implant-specific Geometry |
| Technical Method | Used As Manual Surgical Instruments For Press-fit Osteochondral Implants |
| Target Area | Bones Of The Extremities |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.4505 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBO |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4693 |
| Device | Instruments Designed For Press-fit Osteochondral Implants |
| Product Code | QBO |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 888.4505 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARTIVA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |