FDA Device Establishments · JSON-LD · Markdown
FEI 3015426608 · Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3015426608 |
|---|---|
| Owner / Operator | Medynus, Inc. (#10060045) |
| Address | 18 Technology Dr. Suite 109, Irvine, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 2 |
| Product codes (top 20) | ODP, MAX |
| Regulation § (21 CFR) | 888.3080 |
| Proprietary names | CCN-00013 (AC.2109) ACDF Trial (Lordotic) L14 x W14 x A7 x H9; CCN-00011 (AC.2107) ACDF Trial (Lordotic) L14 x W14 x A7 x H7; Pixie (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage; Cervical Cage Container (CCT-00001); Trial Anatomic dual 14*16*11-12mm; Trial Lordotic dual 14*16*5-6mm; Trial Lordotic dual 12*14*11-12mm; Trial Anatomic 14*16*10mm (CCN-00030); Trial Lordotic 12*14*8mm (CCN-00004); Trial Anatomic 14*16*9mm (CCN-00029) |
Source: openFDA. Public-domain (CC0).