FDA.reportPublic FDA data

TLS 5.0

Primary DI
B0301000501400
Brand
TLS 5.0
Company
CAMBER SPINE TECHNOLOGIES, LLC
Model
100-05-0140
Device description
"T-Handle, QC, 1/4"" Square Adapter"
Published
2023-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0301000501400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(484) 427-7060quality@cambermedtech.com

Regulatory Flags#

DUNS number
054205979
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B030SPO1530020VARIANTSPO-153-0022022-11-25
B030TLP420WR0Alcantara™ Thoracolumbar PlatingTLP-420WR2025-08-01
B030TLP422WR0Alcantara™ Thoracolumbar PlatingTLP-422WR2025-08-01
B030TLP424WR0Alcantara™ Thoracolumbar PlatingTLP-424WR2025-08-01
B030TLP426WR0Alcantara™ Thoracolumbar PlatingTLP-426WR2025-08-01
B030TLP428WR0Alcantara™ Thoracolumbar PlatingTLP-428WR2025-08-01
B030TLP430WR0Alcantara™ Thoracolumbar PlatingTLP-430WR2025-08-01
B030TLP432WR0Alcantara™ Thoracolumbar PlatingTLP-432WR2025-08-01
B030TLP434WR0Alcantara™ Thoracolumbar PlatingTLP-434WR2025-08-01
B030TLP436WR0Alcantara™ Thoracolumbar PlatingTLP-436WR2025-08-01
B030TLP438WR0Alcantara™ Thoracolumbar PlatingTLP-438WR2025-08-01
B030TLP440WR0Alcantara™ Thoracolumbar PlatingTLP-440WR2025-08-01
B030TLP1000Alcantara Thoracolumbar PlatingTLP-100NA2024-07-18
B030TLP2180Alcantara Thoracolumbar PlatingTLP-218NA2024-07-18
B030TLP2200Alcantara Thoracolumbar PlatingTLP-220NA2024-07-18
B030TLP2220Alcantara Thoracolumbar PlatingTLP-222NA2024-07-18
B030TLP2240Alcantara Thoracolumbar PlatingTLP-224NA2024-07-18
B030TLP2260Alcantara Thoracolumbar PlatingTLP-226NA2024-07-18
B030TLP2280Alcantara Thoracolumbar PlatingTLP-228NA2024-07-18
B030TLP2350Alcantara Thoracolumbar PlatingTLP-235NA2024-07-18

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