Lucent® XP
Spinal Elements
Spinal Elements
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012341129 | 3012341129 | Spinal Elements | 1 | N | 2020-04-25 | 47354 Fremont Blvd. Fremont CA US 94538 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 194781 | 1404289978 | K113533 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | HAE | 2012-04-11 |
| 194781 | 1875809828 | K110696 | NEURO CHECK DEVICE WITH IO-FLEX WIRE | ETN | 2011-07-07 |
| 194781 | 1149538551 | K102594 | IO-FLEX CATHETER | BSO | 2011-01-19 |
| 194781 | 1094179653 | K100958 | MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES | HAE | 2010-07-23 |
Product Codes Associated With Registrations#
PMN#
GUDID#
ZEUS-T - TUBE TLIF TRIALS 28L X 07H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 08H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 09H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 10H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 11H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 12H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 13H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 14H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 28L X 15H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 08H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 09H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 10H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 11H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 12H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 13H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 14H
2020-12-04
ZEUS-T - TUBE TLIF TRIALS 36L X 15H
2020-12-04
ZEUS-O - DISC SHAPER EXPANDABLE RASP
2020-05-11
ZEUS-L - CONTRAST PUCK WITH DILATOR SLOT
2020-05-11
SAVANNAH-T - SAVANNAH®-T ALIGNMENT SLEEVE
2020-05-05
TALON - COUNTER TORQUE
2020-05-05
TALON - SPECIAL BONE AWL
2020-05-05
SAVANNAH - MIS COUNTER TORQUE TUBE
2020-05-04
SAVANNAH - MIS COUNTER TORQUE WRENCH
2020-05-04
SAVANNAH - SPECIAL SCREW ADJUSTER
2020-04-29
SAVANNAH - 18 INCH PEDICLE SCREW DEPTH GAUGE
2020-04-29
SAVANNAH - MIS TULIP POSITIONER
2020-04-29
SAVANNAH - SET SCREW DRIVER WITH FRICTION FIT
2020-04-29
SAVANNAH - SHORT RIGHT ANGLE ROD INSERTER
2020-04-29
SAVANNAH - 90° CURVED ROD INSERTER
2020-04-29
ZEUS-A - ZEUS-A POPSICLE TRIAL CONNECTED TO OBLIQUE HOLE
2020-04-28
ZEUS-T - NON-INSULATED LATERAL DILATORS
2020-04-28
ZEUS-P - NON CUTTIG PADDLE DISTRACTERS 7MM
2020-04-28
ZEUS-T - 36 MM MIS TLIF -BULLETNOSE TRIALS
2020-04-28
ZEUS-C - ZEUS CERVICAL RASP SET
2020-04-28
ZEUS-T - WELD TEDAN RETRACTOR JOINTS
2020-04-28
ZEUS-A - 42MM LOLIPOP TRIALS
2020-04-28
ZEUS-P - NON CUTTING PADDLE DISTRACTERS 8MM
2020-04-28
ZEUS-P - NON CUTTING PADDLE DISTRACTERS 9MM
2020-04-28
ZEUS-P - NON CUTTING PADDLE DISTRACTERS 10MM
2020-04-28