FDA Registration
Active
🇺🇸 United States
T-SRO (TLSO), LARGE
Reg #: 2031918
·
FEI: 3002935344
·
Expires 2025
Products
1
Proprietary Names
94
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TIBURON MEDICAL ENTERPRISES
- Registration Number
- 2031918
- FEI Number
- 3002935344
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 915 INDUSTRIAL WAY
- City
- SAN JACINTO
- State
- CA
- ZIP
- 92582
- Country
- US
Owner / Operator
- Firm Name
- TIBURON MEDICAL ENTERPRISES
- Operator Number
- 9040187
- Address
- 915 INDUSTRIAL WAY, --
- City
- San Jacinto
- State
- CA
- Postal Code
- 92582
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2004-02-05 |
Proprietary Names
T-SRO (TLSO), LARGE
LS20003 - SOFT RIDGE ORTHOSIS W/STANDARD FRONT, MEDIUM
Posterior Draw LSO for Shadow Modular Spinal System, Average Medium
TLSO SOFT RIGID ORTHOSIS, SMALL
LS20106 - SOFT RIDGE ORTHOSIS W/PENDULOUS FRONT, EXTRA-EXTRA LARGE
Frame, Shadow LSO Avg/Tall, Medium
LSO KYDEX CHAIRBACK BRACE, SM
LS20102 - SOFT RIDGE ORTHOSIS W/PENDULOUS FRONT, SMALL
Posterior Draw LSO for Shadow Modular Spinal System, Average 3-Xtra Large
LINER, REPLACEMENT, COMFORT MAX CHAIRBACK, MEDIUM
SRO, SMALL
COMFORT MAX CHAIRBACK BRACE,M
SHADOW MODULAR SPINAL SYSTEM, TALL, MEDIUM
LSO KYDEX CHAIRBACK BRACE, MED
LS20103 - SOFT RIDGE ORTHOSIS W/PENDULOUS FRONT, MEDIUM
Posterior Draw LSO for Shadow Modular Spinal System, Tall Small
TLSO KDX CHRBK W/THRCC EX, X-L
T-SRO (TLSO), XTRA-LARGE
LS20004 - SOFT RIDGE ORTHOSIS W/STANDARD FRONT, LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Average Large
LINER, REPLACEMENT, COMFORT MAX CHAIRBACK, LARGE
BACK PANEL, SMALL
Posterior Draw LSO for Shadow Modular Spinal System, Tall 2-Xtra Large
Ext. Kit for LSO Chrbck, Sm/Md
LS20005 - SOFT RIDGE ORTHOSIS W/STANDARD FRONT, EXTRA LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Average Extra Large
TLSO KDX CHRBK W/THRCIC EX, LG
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, 3X-LARGE
TLSO SOFT RIGID ORTHOSIS, XTRA-LARGE
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, LARGE
Front Panel, Shadow LSO Avg/Tall, Small/Medium/Large
79-63107 Chairback Xtr-Large
TLSO KDX CHRBK W/THRCC EX, MED
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, 2X-LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Average Small
Corset Front For Spinal Products, Extra Large
T-SRO, (TLSO) SMALL
TLSO SOFT RIGID ORTHOSIS, XX LARGE
LSO KYDEX CHRBCK BRACE, XTR LG
Beige Chairback Brace, Large
LS20105 - SOFT RIDGE ORTHOSIS W/PENDULOUS FRONT, EXTRA LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Tall Large
Beige Chairback Brace, Small
Corset Front For Spinal Products, Small
Front Plate Only, For ComfortMax ChairBack, Fits all Chairback Sizes, Universal
LS22006 TLSO SRO COMPLETE W/STANDARD FRONT PANEL, 2X-LARGE
Frame, Shadow LSO Avg/Tall, Small
SRO, MEDIUM
SRO, LARGE
BACK PANEL, LARGE
T-SRO (TLSO), 2X-LARGE
COMFORT MAX CHAIRBACK BRACE,S
SHADOW MODULAR SPINAL SYSTEM, TALL, SMALL
Ext. Kit for LSO Chrbck Lg/Xlg
LS20006 - SOFT RIDGE ORTHOSIS W/STANDARD FRONT, EXTRA-EXTRA LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Average 2-Xtra Large
LS22005 TLSO SRO COMPLETE W/STANDARD FRONT PANEL, XTRA-LARGE
SHADOW MODULAR SPINAL SYSTEM, TALL, 3X-LARGE
LSO KYDEX CHAIRBACK BRACE, LG
LS20104 - SOFT RIDGE ORTHOSIS W/PENDULOUS FRONT, LARGE
Posterior Draw LSO for Shadow Modular Spinal System, Tall Medium
SRO, 2X
LS22003 TLSO SRO COMPLETE W/STANDARD FRONT PANEL, MEDIUM
SHADOW MODULAR SPINAL SYSTEM, TALL, EXTRA-LARGE
LINER, REPLACEMENT, COMFORT MAX CHAIRBACK, SMALL
TLSO SOFT RIGID ORTHOSIS, LARGE
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, MEDIUM
Frame, Shadow LSO Avg/Tall, Extra-Large, 2XLg, 3XLg
LINER, REPLACEMENT, COMFORT MAX CHAIRBACK, EXTRA LARGE
79-63110 DJ Chairback - Large
SRO, EXTRA-LARGE
LS22002 TLSO SRO COMPLETE W/STANDARD FRONT PANEL, SMALL
Corset Front For Spinal Products, Large
STANDARD FRONT PANEL
LS22004 TLSO SRO COMPLETE W/STANDARD FRONT PANEL, LARGE
SHADOW MODULAR SPINAL SYSTEM, TALL, 2X-LARGE
COMFORT MAX CHAIRBACK BRACE,L
PENDULOUS FRONT PANEL
SHADOW MODULAR SPINAL SYSTEM, TALL, LARGE
T-SRO(TLSO), MEDIUM
LS20002 - SOFT RIDGE ORTHOSIS LS W/STANDARD FRONT, SMALL
Beige Chairback Brace, Extra Large
Posterior Draw LSO for Shadow Modular Spinal System, Tall Extra Large
COMFORT MAX CHAIRBACK BRACE,XL
REPLACEMENT STRAPS FOR #0825
Beige Chairback Brace, medium
TLSO KDX CHRBK W/THRCIC EX, SM
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, EXTRA-LARGE
Front Panel, Shadow LSO Avg/Tall, Xtra-Large/2Xlg/3Xlg
Corset Front For Spinal Products, Medium
TLSO SOFT RIGID ORTHOSIS, MEDIUM
SHADOW MODULAR SPINAL SYSTEM, AVERAGE, SMALL
Frame, Shadow LSO Avg/Tall, Large
79-63109 DJ Chrback Frame Med
Establishment Types
Manufacture Medical Device