Instruments Designed For Press-fit Osteochondral Implants

Device Code: 4693

Product Code(s): QBO

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 Classification Information

Device Type ID4693
Device NameInstruments Designed For Press-fit Osteochondral Implants
Physical StateSmooth, Metallic, With Implant-specific Geometry
Technical MethodUsed As Manual Surgical Instruments For Press-fit Osteochondral Implants
Target AreaBones Of The Extremities
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Restorative And Repair Devices Branch (RRDB)
Submission Type510(k)
CFR Regulation Number888.4505 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeQBO
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4693
DeviceInstruments Designed For Press-fit Osteochondral Implants
Product CodeQBO
FDA Device ClassificationClass 2 Medical Device
CFR Regulation Number888.4505 [🔎]
Premarket Reviews
ManufacturerDecision
CARTIVA, INC.
 
SUBSTANTIALLY EQUIVALENT
1
TPLC Last Update: 2019-04-02 20:54:00

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