FDA.reportPublic FDA data

Tranquil-C Interbody System

Primary DI
B678522967S0
Brand
Tranquil-C Interbody System
Company
NEXUS SPINE, L.L.C.
Model
522967S
Device description
Cervical IBD 8x16x13 Planar, 6 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
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240416000Tranquil-C Interbody SystemNexus Spine, LLC2024-03-12ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678522967S0PrimaryHIBCC0

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
Height8Millimeter
Length13Millimeter
Width16Millimeter

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
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCODP2026-08-03
M719G45170Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
M719G45180Stasys-C StandaloneGenesys Orthopedics Systems LLCOVE2026-08-03
00889929072929HONOUR® Spacer SystemNEXXT SPINE, LLCODP2026-07-29