Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K181397
DualX · Innovasive, Inc. · decided 2018-09-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| DUALX DUAL PORTAL SCOPE CANNULA SELF RETRACTOR FUSION | USCH3 | AMPLIFY SURGICAL, INC. | MAX | B707USCH30 |
| DUALX DUAL PORTAL MICRO PITUITARY STRAIGHT 2.0mm | 0800118 | AMPLIFY SURGICAL, INC. | MAX | B70708001180 |
| DUALX DUAL PORTAL DOUBLE ENDED DISSECTOR 3.0mm | NHD1903US | AMPLIFY SURGICAL, INC. | MAX | B707NHD1903US0 |
| KIT DUALX LLIF 13-16MM x 7 DEG x 40MM | 12833007026 | AMPLIFY SURGICAL, INC. | MAX | B707128330070260 |
| DUALX LLIF 10-13MM x 7 DEG x 55MM | 12831007014 | AMPLIFY SURGICAL, INC. | MAX | B707128310070140 |
| DUALX LLIF 10-13MM x 12 DEG x 45MM | 12831000007 | AMPLIFY SURGICAL, INC. | MAX | B707128310000070 |
| DUALX PLIF 0 DEG x 7-9MM | 12821000001 | AMPLIFY SURGICAL, INC. | MAX | B707128210000010 |
| DUALX DUAL PORTAL CANNULA 80MM | 12535588006US | AMPLIFY SURGICAL, INC. | MAX | B70712535588006US0 |
| DUALX TLIF TRIAL 13-16MM | 12535400008 | AMPLIFY SURGICAL, INC. | MAX | B707125354000080 |
| KIT DUALX LLIF 10-13MM x 0 DEG x 55MM | 12833005014 | AMPLIFY SURGICAL, INC. | MAX | B707128330050140 |
| DUALX TLIF 0 DEG x 14-17MM | 12531006003 | AMPLIFY SURGICAL, INC. | MAX | B707125310060030 |
| DualX Fixed Drawbar T/PLIF | 12825004 | AMPLIFY SURGICAL, INC. | MAX | B707128250040 |
| DUALX TUBE RETRACTOR 18 X 130MM | 125356001130 | AMPLIFY SURGICAL, INC. | MAX | B7071253560011300 |
| DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA) | 12535574030 | AMPLIFY SURGICAL, INC. | MAX | B707125355740300 |
| DUALX SCREW DRIVER SLEEVE | 12534094 | AMPLIFY SURGICAL, INC. | MAX | B707125340940 |
| DUALX LLIF 10-13MM x 7 DEG x 40MM | 12831007011 | AMPLIFY SURGICAL, INC. | MAX | B707128310070110 |
| DUALX LLIF 14-17MM x 0 DEG x 50MM | 12831005023 | AMPLIFY SURGICAL, INC. | MAX | B707128310050230 |
| DUALX LLIF LOCKOUT SCREW 60MM | 12830008005 | AMPLIFY SURGICAL, INC. | MAX | B707128300080050 |
| DUALX DUAL PORTAL 2.0 CANNULA INSERTER, BETA | 12545020 | AMPLIFY SURGICAL, INC. | MAX | B707125450200 |
| DualX LLIF IMPLANT HOLDER 40mm | 12534146040 | AMPLIFY SURGICAL, INC. | MAX | B70712534146040 |
| KIT DUALX TLIF 8 DEG x 12-15MM | 12533006008 | AMPLIFY SURGICAL, INC. | MAX | B707125330060080 |
| KIT DUALX LLIF 8-11MM x 0 DEG x 40MM | 12833005006 | AMPLIFY SURGICAL, INC. | MAX | B707128330050060 |
| DUALX LLIF 10-13MM x 0 DEG x 40MM | 12831005011 | AMPLIFY SURGICAL, INC. | MAX | B707128310050110 |
| DUALX TUBE RETRACTOR 18 X 150MM | 125356001150 | AMPLIFY SURGICAL, INC. | MAX | B7071253560011500 |
| KIT DUALX LLIF 14-17MM x 7 DEG x 55MM | 12833007034 | AMPLIFY SURGICAL, INC. | MAX | B707128330070340 |