FDA Device Establishments · JSON-LD · Markdown

Kalitec Direct LLC DBA Kalitec Medical

FEI 3009165919 · 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 Number3009165919
Owner / OperatorKalitec Medical (#10037099)
Address1819 Main St Ste 303, Sarasota, FL, US
Registration expiry2026
Initial importer flagN
Registered products1
Product codes (top 20)NKB
Regulation § (21 CFR)888.3070
Proprietary namesNIDO Pedicle Screw System

External sources

Source: openFDA. Public-domain (CC0).