FDA.report

Tranquil-C Interbody System

Primary DI
B6785224600
Brand
Tranquil-C Interbody System
Company
NEXUS SPINE, L.L.C.
Model
522460
Device description
Cervical IBD 12x20x15 Planar, 6 Deg
Published
2025-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions

SubmissionSupplement
K240416000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240416000Tranquil-C Interbody SystemNexus Spine, LLC2024-03-12ODP

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6785224600PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Depth15Millimeter
Height12Millimeter
Width20Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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