True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
Innovative-Surgical-Designs
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010586931 | 3010586931 | INNOVATIVE SURGICAL DESIGNS, INC. | 1 | N | 2020-04-25 | 3903 S Walnut St Bloomington IN US 47401 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 168013 | 2037228360 | K181584 | Redi-Spine | NKB | 2018-08-10 |
| 168013 | 1363449453 | K171559 | True Spinal Fixation System | NKB | 2017-07-24 |
| 168013 | 1072281110 | K170710 | True Spinal Fixation System | NKB | 2017-07-14 |
| 168013 | 1184136622 | K133690 | TRUE SPINAL FUSSION SYSTEM | MNH | 2014-05-07 |
| 168013 | 1423379876 | K130958 | TRUE SPINAL FIXATION SYSTEM | MNI | 2013-10-17 |
| 168013 | 1212446774 | ||||
| 168013 | 1389728420 | ||||
| 168013 | 1430277722 | ||||
| 168013 | 1686783075 | ||||
| 168013 | 1764328084 | ||||
| 168013 | 1769562059 |
Product Codes Associated With Registrations#
PMN#
True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
True Tulip System, True M.I.S. System
Innovative Surgical Designs, Inc.
Redi-Spine
Innovative Surgical Designs, Inc.
True Spinal Fixation System
Innovative Surgical Designs, Inc.
True Spinal Fixation System
Innovative Surgical Designs, Inc.
TRUE SPINAL FUSSION SYSTEM
INNOVATIVE SURGICAL DESIGNS
TRUE SPINAL FIXATION SYSTEM
INNOVATIVE SURGICAL DESIGNS
GUDID#
True Tulip Spinal Fixation System - 5.5 mm x 35 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 5.5 mm x 35 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 5.5 mm x 45 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 5.5 mm x 50 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 6.5 mm x 35 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 6.5 mm x 40 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 6.5 mm x 45 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 6.5 mm x 50 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 7.5 mm x 35 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 7.5 mm x 40 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 7.5 mm x 45 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - 7.5 mm x 50 mm True MIS Pedicle Screw
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 30 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 35 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 40 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 45 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 50 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 55 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 60 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 65 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 75 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 85 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 95 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 105 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Lordotic Titanium Rods, 5.5 mm x 115 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 30 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 35 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 40 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 45 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 50 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 55 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 60 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 65 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 75 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 85 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 95 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 105 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 115 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 150 mm
2020-02-11
True Tulip Spinal Fixation System - MIS Straight Titanium Rods, 5.5 mm x 200 mm
2020-02-11