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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 27092 Burbank, Foothill Ranch, CA, 92610
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015255331
- DUNS Number
- —
Catalogue (420)
Page 9 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DualXS Fixed ACME Drawbar | 12845001 | FDA UDI | Class II | Active |
| Dualx Dual Portal Squire Curette Up | SCR20UP | FDA UDI | Class II | Active |
| DUALX LLIF 8-11MM x 7 DEG x 50MM | 12831007003 | FDA UDI | Class II | Active |
| DUALX LLIF 7-9MM x 0 DEG x 40MM | 12831005001 | FDA UDI | Class II | Active |
| KIT DUALX LLIF 10-13MM x 12 DEG x 40MM | 12832000006 | FDA UDI | Class II | Active |
| DUALX DUAL PORTAL CURETTE UP 3.0mm | QU332130 | FDA UDI | Class II | Active |
| KIT DUALX PLIF 12 DEG x 10-12MM | 12823001016 | FDA UDI | Class II | Active |
| DUALX LLIF 13-16MM x 7 DEG x 55MM | 12831007029 | FDA UDI | Class II | Active |
| KIT DUALX LLIF 10-13MM x 7 DEG x 55MM | 12833007014 | FDA UDI | Class II | Active |
| Dualx Llif Trial 9-12mm | 12835005003 | FDA UDI | Class II | Active |
| KIT DUALX LLIF 11-14MM x 7 DEG x 55MM | 12833007019 | FDA UDI | Class II | Active |
| Dualx Tlif Trial 13-16mm | 12535400008 | FDA UDI | Class II | Active |
| KIT DUALX PLIF 12 DEG x 10-12MM | 12822001016 | FDA UDI | Class II | Active |
| KIT DUALX LLIF 12-15MM x 7 DEG x 45MM | 12833007022 | FDA UDI | Class II | Active |
| KIT DUALX LLIF 8-11MM x 7 DEG x 55MM | 12832007004 | FDA UDI | Class II | Active |
| Dualx Llif Lockout Screw 2 X 55mm | 12830009004 | FDA UDI | Class II | Active |
| DUALX LLIF 8-11MM x 7 DEG x 60MM | 12831007005 | FDA UDI | Class II | Active |
| DualXSLIM(R) T/PLIF | K222203 | FDA 510(k) | Class II | Active |
| DualX | K211740 | FDA 510(k) | Class II | Active |
| DualX Lumbar Intervertebral Body Fusion Device | K192434 | FDA 510(k) | Class II | Active |
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