FDA.reportPublic FDA data

Tranquil-C Interbody System

Primary DI
B678522374S0
Brand
Tranquil-C Interbody System
Company
NEXUS SPINE, L.L.C.
Model
522374S
Device description
Cervical IBD 6x18x14, Planar, 12 deg
Published
2025-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170297000Tranquil Interbody SystemNexus Spine, LLC2017-06-27MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678522374S0PrimaryHIBCC0

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
Height6Millimeter
Length14Millimeter
Width18Millimeter

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B678520297S0PressON™520297S2026-07-10
B678520298S0PressON™520298S2026-07-10
B678520299S0PressON520299S2026-07-10
B678520300S0PressON™520300S2026-07-10
B678520301S0PressON520301S2026-07-10
B678520302S0PressON™520302S2026-07-10
B678520303S0PressON520303S2026-07-10
B678520304S0PressON™520304S2026-07-10
B678520305S0PressON520305S2026-07-10
B678520306S0PressON™520306S2026-07-10
B678520485S0PressON Pedicle Screw System520485S2026-07-10
B678520486S0PressON Pedicle Screw System520486S2026-07-10
B678520487S0PressON Pedicle Screw System520487S2026-07-10
B678520488S0PressON Pedicle Screw System520488S2026-07-10
B678520489S0PressON Pedicle Screw System520489S2026-07-10
B678520490S0PressON Pedicle Screw System520490S2026-07-10
B678520491S0PressON Pedicle Screw System520491S2026-07-10
B678520492S0PressON Pedicle Screw System520492S2026-07-10
B678520493S0PressON Pedicle Screw System520493S2026-07-10
B678520494S0PressON Pedicle Screw System520494S2026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166523028X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
04251631420095NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420101NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420118NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420125NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420132NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420149NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420156NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420163NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420170NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420187NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631420194NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421153BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421177BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421184BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421207BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421214BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421221BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421252BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421269BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421276BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421283BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421306BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421313BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421320BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421337BEE PLIF CageNGMedical GmbHMAX2026-07-30
04251631421351BEE PLIF CageNGMedical GmbHMAX2026-07-30