Knee Arthroplasty Implantation System
The Knee Arthroplasty Implantation System (product code OOG) is a Class 2 orthopedic device regulated under 21 CFR 888.3560 in the Orthopedic specialty (OR), cleared via 510(k). It is a surgical instrument system intended to assist in the implantation of specific knee arthroplasty devices, including guiding alignment, making bone cuts, selecting and sizing implant components, and positioning or orienting components during total or partial knee replacement surgery. The device is a surgical tool rather than an implant itself, and is not life-sustaining.
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Basic Information
- Product Code
- OOG
- Device Class
- FDA class 2
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Intended to be used to assist in the implantation of a specific knee arthroplasty device or a set of specific knee arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.
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 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.