FDA.reportPublic FDA data

Tranquil-L™

Primary DI
B6788231100
Brand
Tranquil-L™
Company
NEXUS SPINE, L.L.C.
Model
823110
Device description
"15"" Endplate Rasp Str Dbl-Side 7"" Handle"
Published
2022-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170297000
K181483000
K181702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170297000Tranquil Interbody SystemNexus Spine, LLC2017-06-27MAX
K181483000Tranquil Interbody SystemNexus Spine, LLC2018-08-27MAX
K181702000Tranquil-L Interbody SystemNexus Spine, LLC2018-09-21MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6788231100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785220130Tranquil-L™5220132021-12-17
B6785220140Tranquil-L™5220142021-12-17
B6785220150Tranquil-L™5220152021-12-17
B6785220160Tranquil-L™5220162021-12-17
B6785220170Tranquil-L™5220172021-12-17
B6785220180Tranquil-L™5220182021-12-17
B6785220190Tranquil-L™5220192021-12-17
B6785220200Tranquil-L™5220202021-12-17
B6785220210Tranquil-L™5220212021-12-17
B6785220220Tranquil-L™5220222021-12-17
B6785220120Tranquil-L™5220122021-12-17
B6785229040Tranquil-L™5229042021-12-17
B6785229050Tranquil-L™5229052021-12-17
B6785229060Tranquil-L™5229062021-12-17
B6785229070Tranquil-L™5229072021-12-17
B6785229080Tranquil-L™5229082021-12-17
B6785229090Tranquil-L™5229092021-12-17
B6785229100Tranquil-L™5229102021-12-17
B6785229110Tranquil-L™5229112021-12-17
B6785229120Tranquil-L™5229122021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00199150082865Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082872Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
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