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 | ||
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Manufacturer | Decision | |
CARTIVA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |