1 device · 1 company · 2023
Product code OOG: Knee Arthroplasty Implantation System
1 device under product code OOG, 2023, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Knee Arthroplasty Implantation System. 21 CFR 888.3560, Class II. 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. MAUDE held 260 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| United Orthopedic Knee Patient Specific InstrumeK230850 · 510(k) | Enhatch, Inc. | Orthopedic | database entry |
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