Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSURGENTEC LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 911 Clint Moore Rd, Boca Raton, FL, 33487
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3012495575
- DUNS Number
- —
Catalogue (306)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 5.5mm Drill Bit | SR12-6009 | FDA UDI | U | Active |
| Universal Graftgun Kit | RED-U-1000 | FDA UDI | Class II | Active |
| GraftRasp Teeth and Set Screw - Bladed | 3D-D05-07 | FDA UDI | Class I | Active |
| Medium Axial AO Ratcheting Handle | SR12-5000 | FDA UDI | U | Active |
| TILink-P Drill Guide Dilator Assembly - 5mm | SR16-2105 | FDA UDI | Class II | Active |
| Disposable Pin Puller | SR20-1300 | FDA UDI | Class II | Active |
| ALARA Neuro Access Needle Kit | AAN-09-NS | FDA UDI | Class II | Active |
| Decortication Rasp- Straight | 3D-D05-04 | FDA UDI | Class I | Active |
| BMAC Diamond Needle | SR07-1300 | FDA UDI | Class II | Active |
| Plastic Drill Guide | SR12-6002 | FDA UDI | U | Active |
| GraftGun Universal Graft Delivery System - Additional 5cc Graft Tube - IOSAL | GG-T-01-IB | FDA UDI | Class II | Active |
| Global Tip Adapter Package | RED-NTA-04 | FDA UDI | Class II | Active |
| TiLink-P Screw 12mm x 30mm | SI-SGT-30 | FDA UDI | Class II | Active |
| BMAC Diamond Needle - Two Pack | SR07-1302 | FDA UDI | Class II | Active |
| Bullet Global Tip Adapter | GG-NTA-13 | FDA UDI | Class II | Active |
| TiLink-L Reamer | SR21-6008 | FDA UDI | Class II | Active |
| ION implant caddy large | SR12-7006 | FDA UDI | U | Active |
| BMAN Solid Diamond Needle Kit | SR07-1101 | FDA UDI | Class II | Active |
| SI Screw Drill Bit 25mm 1/4 | SR16-6226 | FDA UDI | Class II | Active |
| TILink-P Anchor 14mm 3D | SR16-4301 | FDA UDI | Class II | Active |
| ALARA Neuro Access Needle Kit | AAN-09-NHS | FDA UDI | Class II | Active |
| OsteoFlo Synthetic NanoPutty Syringe- 510cc | ONP-S-10 | FDA UDI | Class II | Active |
| OsteoFlo Synthetic HydroPutty HFP - 12cc | OHFP-S-12 | FDA UDI | Class II | Active |
| Disposable Impactor | SR19-3000 | FDA UDI | U | Active |
| 5cc Graft Tube Pusher | GG-GTP-01 | FDA UDI | Class II | Active |
| TiLink-L Implant 40mm x 10mm | SI-L-40 | FDA UDI | Class II | Active |
| OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10cc | ONP-U-10 | FDA UDI | Class II | Active |
| TILink-P Graft Rasp | SR16-3900 | FDA UDI | Class II | Active |
| SI Screw Inserter Threaded Rod Assembly - 3mm | SR16-6430 | FDA UDI | Class II | Active |
| Impact Cap | SR16-6600 | FDA UDI | Class II | Active |
| Ion-C | K251714 | FDA 510(k) | U | Active |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | K240664 | FDA 510(k) | Class II | Active |
| TiLink-L Navigation Instruments | K253604 | FDA 510(k) | Class II | Active |
| 3D GraftRasp System | K200431 | FDA 510(k) | Class II | Active |
| OsteoFlo® HydroPutty™ | K231716 | FDA 510(k) | Class II | Active |
| GraftGun Universal Graft Delivery System (GDS) | K243580 | FDA 510(k) | Class II | Active |
| Graftgun Universal Graft Delivery System | K180937 | FDA 510(k) | Class II | Active |
| Ion 3D | K240086 | FDA 510(k) | U | Active |
| OsteoFlo HydroFiber | K242797 | FDA 510(k) | Class II | Active |
| TiLink-P SI Joint Fusion System | K240720 | FDA 510(k) | Class II | Active |
| ALARA Neuro Access Kit | K190163 | FDA 510(k) | Class II | Active |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | K243945 | FDA 510(k) | Class II | Active |
| OsteoFlo HydroFiber | K243949 | FDA 510(k) | Class II | Active |
| TiLink-L SI Joint Fusion System | K230446 | FDA 510(k) | Class II | Active |
| TiLink-P Joint Fusion System | K242414 | FDA 510(k) | Class II | Active |
| TiLink-P SI Joint Fusion System | K242141 | FDA 510(k) | Class II | Active |
| OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft | K200064 | FDA 510(k) | Class II | Active |
| Graftgun Universal Graft Delivery System | K170675 | FDA 510(k) | Class II | Active |
| 3D GraftRasp System | K201900 | FDA 510(k) | Class II | Active |
| OsteoFlo HydroFiber | K251720 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.