FDA Device Establishments · JSON-LD · Markdown
FEI 3006460162 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3006460162 |
|---|---|
| Owner / Operator | ORTHOPEDIATRICS, CORP (#9102640) |
| Address | 2850 Frontier Dr, Warsaw, IN, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 2 |
| Product codes (top 20) | KWP, NKB |
| Regulation § (21 CFR) | 888.3050, 888.3070 |
| Proprietary names | RESPONSE 5.5/6 Spine System; RESPONSE Spine System; RESPONSE 4.5/5 Spine System |
Source: openFDA. Public-domain (CC0).