True Tulip, True M.I.S.
Innovative Surgical Designs, Inc.
INNOVATIVE SURGICAL DESIGNS, INC.
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.