FDA Device Establishments · JSON-LD · Markdown
FEI 3030409224 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3030409224 |
|---|---|
| Owner / Operator | Enhatch, Inc (#10089831) |
| Address | 411 State Rt 17 Ste 500, Hasbrouck Heights, NJ, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | OOG, PBF, LLZ |
| Regulation § (21 CFR) | 888.3560, 888.3030, 892.2050 |
| Proprietary names | Intelligent Surgery Knee; United Orthopedic Knee Patient Specific Instrumentation |
Source: openFDA. Public-domain (CC0).