Instruments Designed For Press-Fit Osteochondral Implants
The Instruments Designed for Press-Fit Osteochondral Implants are orthopedic surgical instruments intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants, used in cartilage repair procedures. It is classified as a Class 2 device under regulation 888.4505, subject to De Novo classification with general and special controls, and falls within the Orthopedic (OR) medical specialty. The product code is QBO. It is not an implant itself and is not life-sustaining.
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Basic Information
- Product Code
- QBO
- Device Class
- FDA class 2
- Regulation Number
- 888.4505
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.