Phantom XL Insulated Dilators
TeDan Surgical Innovations, Inc.
TEDAN SURGICAL INNOVATIONS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005726885 | 3005726885 | TEDAN SURGICAL INNOVATIONS, INC. | 1 | Y | 2026-01-01 | 12320 Cardinal Meadow Drive Suite #150 Sugar Land TX US 77478 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 66702 | 1465302638 | K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | GZT | 2017-03-20 |
| 66702 | 1707409377 | K140088 | PHANTOM XL INSULATED DILATORS | PDQ | 2014-09-25 |
| 66702 | 1059054912 | ||||
| 66702 | 1149726218 | ||||
| 66702 | 1150121894 | ||||
| 66702 | 1304040588 | ||||
| 66702 | 1410058494 | ||||
| 66702 | 1414061254 | ||||
| 66702 | 1432940410 | ||||
| 66702 | 1452319113 | ||||
| 66702 | 1512296683 | ||||
| 66702 | 1527331266 | ||||
| 66702 | 1560021858 | ||||
| 66702 | 1609494641 | ||||
| 66702 | 1714824182 | ||||
| 66702 | 1734751173 | ||||
| 66702 | 1806655457 | ||||
| 66702 | 1030086508 | ||||
| 66702 | 1061842262 | ||||
| 66702 | 1227533619 | ||||
| 66702 | 1346703612 | ||||
| 66702 | 1415506935 | ||||
| 66702 | 1471364391 | ||||
| 66702 | 1485284252 | ||||
| 66702 | 1629542550 | ||||
| 66702 | 1631558045 | ||||
| 66702 | 1658169570 | ||||
| 66702 | 1704895075 | ||||
| 66702 | 1840377168 | ||||
| 66702 | 1849738184 | ||||
| 66702 | 1899483637 | ||||
| 66702 | 1943085349 | ||||
| 66702 | 1950077743 | ||||
| 66702 | 2033328859 |
Product Codes Associated With Registrations#
PMN#
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
TEDAN SURGICAL INNOVATIONS LLC
PHANTOM XL INSULATED DILATORS
TEDAN SURGICAL INNOVATIONS, LLC
GUDID#
Lattus - Lateral Shim Removal Claw
2026-07-20
Lattus - Duet 22 Blade Introducer, Single Slot, Short
2026-07-20
Lattus - Duet 22 Blade Introducer, Double Slot, Short
2026-07-20
Lattus - Instrument Tray, Duet 22mm Split Tubes
2026-07-20
Lattus - Duet 22 Blade Introducer, Single Slot, Long
2026-07-20
Lattus - Duet 22 Blade Introducer, Double Slot, Long
2026-07-20
Lattus - Lateral Handheld W/Shim Fork, Long
2026-07-20
Lattus - Lateral Handheld W/Shim Fork, Short
2026-07-20
Lattus - Lateral Screw Shim Tool
2026-07-20
Lattus - Lateral Screw Shim, Single Use, Non-Sterile
2026-07-20
Lattus - Lateral Extension Shim, Single Use, Non-Sterile
2026-07-20
Lattus - Psoas Utility Device, Long
2026-07-20
Lattus - Psoas Utility Device, Short
2026-07-20
Lattus - ANGLED ARTICULATING ARM, Starburst
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 180MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 170MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 160MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 150MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 140MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 130MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 120MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 110MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 100MM
2026-07-20
Lattus - Duet 22 Split Tube Blade Pair, 90MM
2026-07-20
Lattus - Duet ATP Reverse Lip Blade, 120mm
2026-07-20
Lattus - Duet ATP Standard Lip Blade, 120mm
2026-07-20
Lattus - Duet Handheld Utility Shim Retractor, Long
2026-07-20
Lattus - Duet Handheld Utility Shim Retractor, Short
2026-07-20
Medtronic - STERILE INSULATED DILATOR, 20 MM
2026-04-28
Medtronic - STERILE, NEUROMONITORING DILATOR KIT
2026-04-28
Medtronic - STERILE, INSULATED DILATORS, 5MM, 10MM, 16MM
2026-04-28
3Cor - 14 MM Distraction Screw 1 Per Pack for Single Use Only
2018-08-09
TSI - QUICK START DISTRACTION SCREW, 16 MM
2018-01-10
TSI - QUICK START DISTRACTION SCREW, 14 MM
2018-01-10
TSI - QUICK START DISTRACTION SCREW, 12 MM
2018-01-10
TSI - DISTRACTION SCREW, 16 MM
2018-01-10
TSI - DISTRACTION SCREW, 14 MM
2018-01-10
TSI - DISTRACTION SCREW, 12 MM
2018-01-10
Zimmer - SPIKE K-WIRE SHIM, SINGLE USE ONLY
2017-12-25
Zimmer - "K-WIRE, BLUNT 1.5MM X 350MM (14""), SINGLE USE "
2017-12-25