FDA Device Establishments · JSON-LD · Markdown
FEI 3021286087 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3021286087 |
|---|---|
| Owner / Operator | Tensor Surgical, Inc. (#10083936) |
| Address | 6345 S Pecos Rd Ste 212, Las Vegas, NV, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LXH |
| Regulation § (21 CFR) | 888.4540 |
| Proprietary names | TransOs Suture Fixation Implant System 4020; VersaTip Suture Passer Tip, 40 degree Left, 5/box; TransOs Tunneler Nut (component); TransOs SutureTape Fixation Implant System 5020; TransOs Tunneler Handle (component); TransOs Tunneler Shoulder Pro Instrument Set; TransOs Tunneler Medial Awl w/Microfracture Tip; VersaTip Suture Passer Tip, 60 degree Retrograde, 5/box; VersaTip Suture Passer Snare, 5/box; VersaTip Hip Suture Passer Tip, 60 degree Retrograde, 5/box |
Source: openFDA. Public-domain (CC0).