FDA.reportPublic FDA data

Renovo Life

Primary DI
M734RNLA200150
Brand
Renovo Life
Company
RENOVO LIFE LLC
Model
RNLA20015
Catalog number
RNL-A20015
Device description
T-Wrench
Published
2019-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M734RNLA200150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-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, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
059066475
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M734RNLC300280RENOVO LIFE LLCRNLC30028RNL-C300282019-10-28
M734RNLC300290RENOVO LIFE LLCRNLC30029RNL-C300292019-10-28
M734RNLC300300RENOVO LIFE LLCRNLC30030RNL-C300302019-10-28
M734RNLC300310Renovo LifeRNLC30031RNL-C300312019-10-28
M734RNLC300320Renovo LifeRNLC30032RNL-C300322019-10-28
M734RNLC300330Renovo LifeRNLC30033RNL-C300332019-10-28
M734RNLC300340Renovo LifeRNLC30034RNL-C300342019-10-28
M734RNLC300650Renovo LifeRNLC30065RNL-C300652019-10-28
M734RNLA20008200Renovo LifeRNLA2000820RNL-A20008-202019-10-28
M734RNLA20008250Renovo LifeRNLA2000825RNL-A20008-252019-10-28
M734RNLA20008300Renovo LifeRNLA2000830RNL-A20008-302019-10-28
M734RNLA20008350Renovo LifeRNLA2000835RNL-A20008-352019-10-28
M734RNLA20008400Renovo LifeRNLA2000840RNL-A20008-402019-10-28
M734RNLA20008450Renovo LifeRNLA2000845RNL-A20008-452019-10-28
M734RNLA20008500Renovo LifeRNLA2000850RNL-A20008-502019-10-28
M734RNLA200140Renovo LifeRNLA20014RNL-A200142019-10-28
M734RNLA200130Renovo Life, LLCRNL-A20013RNL-A200132018-01-09
M734RNL3101900Renovo Life, LLCRNL-310-190RNL-310-1902017-11-14
M734RNL310190C0Renovo Life, LLCRNL-310-190-CRNL-310-190-C2017-11-14
M734RNL3102150Renovo Life, LLCRNL-310-215RNL-310-2152017-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373076PERLA ® TLSpineArt SAHXX2026-05-07
09120125220259Shark Screw® driver aclsurgebright GmbHHXX2026-04-30
08806373894213LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373899720LOSPA/BENCOXCorentec Co., LtdHXX2026-04-10
08806373887789BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
08806373892660BENCOX Surgical InstrumentsCorentec Co., LtdHXX2026-01-12
07640332475294PERLA ®SpineArt SAHXX2025-11-10
07640332475300PERLA ®SpineArt SAHXX2025-11-10
07640332475317PERLA ®SpineArt SAHXX2025-11-10
08059386744253Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-06
08059386742266Orthopaedic Surgical InstrumentsCITIEFFE SRLHXX2025-11-05
09348215164737Turbine X Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164744Turbine X Driver – RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164751MI (Mini Incision) Driver - RedSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164768MI (Mini Incision) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215164775O (Turbine OP) Driver - GreenSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151650172.9 Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165024Vector Knotted DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
093482151651235.5 Knotless DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165130Screw DriverSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165178Simple Driver (Black)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165185Simple Driver (Orange)SIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165208Tendonesis Chamfer ReamerSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
09348215165284Staple ShaftSIGNATURE ORTHOPAEDICS PTY LTDHXX2025-10-10
G791CDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
G791SDRASS200WishFIXRed Star Contract Manufacturing Inc.HXX2025-10-06
09120125220037Shark Screw® couplingsurgebright GmbHHXX2025-09-16
09120125220228Shark Screw® driversurgebright GmbHHXX2025-09-16
08800071006848Surgical InstrumentOSTEONIC CO.,Ltd.HXX2025-06-24
08800071024248SignexOSTEONIC CO.,Ltd.HXX2025-06-24