FDA.reportPublic FDA data

Tranquil-L™

Primary DI
B6785221450
Brand
Tranquil-L™
Company
NEXUS SPINE, L.L.C.
Model
522145
Device description
PLIF IBD 8x9x28, Convex, 0 Deg
Published
2021-12-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

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
B6785221450PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

Regulatory Flags#

DUNS number
028137605
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785221380Tranquil-L™5221382021-12-17
B6785221390Tranquil-L™5221392021-12-17
B6785221400Tranquil-L™5221402021-12-17
B6785221410Tranquil-L™5221412021-12-17
B6785221420Tranquil-L™5221422021-12-17
B6785221430Tranquil-L™5221432021-12-17
B6785221440Tranquil-L™5221442021-12-17
B6785221460Tranquil-L™5221462021-12-17
B6785221470Tranquil-L™5221472021-12-17
B6785221480Tranquil-L™5221482021-12-17
B6785221490Tranquil-L™5221492021-12-17
B6785221500Tranquil-L™5221502021-12-17
B6785221510Tranquil-L™5221512021-12-17
B6785221520Tranquil-L™5221522021-12-17
B6785221530Tranquil-L™5221532021-12-17
B6785221540Tranquil-L™5221542021-12-17
B6785221550Tranquil-L™5221552021-12-17
B6785221560Tranquil-L™5221562021-12-17
B6785221570Tranquil-L™5221572021-12-17
B6785221330Tranquil-L™5221332021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900473EARP, 14X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900497EARP, 14X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900534EARP, 18X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900541EARP, 18X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900572EARP, 18X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900589EARP, 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900619EARP, 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900626EARP, 18X35X14 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900633EARP, 18X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16