FDA.reportPublic FDA data

Tranquil-C™

Primary DI
B678522211S0
Brand
Tranquil-C™
Company
NEXUS SPINE, L.L.C.
Model
522211S
Device description
Cervical IBD 7x14x12 Planar 6 Deg
Published
2026-10-30
Public version status
New
Distribution status
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170297000
K181483000
K240416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170297000Tranquil Interbody SystemNexus Spine, LLC2017-06-27MAX
K181483000Tranquil Interbody SystemNexus Spine, LLC2018-08-27MAX
K240416000Tranquil-C Interbody SystemNexus Spine, LLC2024-03-12ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B678522211S0PrimaryHIBCC0

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
B678522207S0Tranquil-C™522207S2026-10-30
B678522208S0Tranquil-C™522208S2026-10-30
B678522209S0Tranquil-C™522209S2026-10-30
B678522210S0Tranquil-C™522210S2026-10-30
B678522212S0Tranquil-C™522212S2026-10-30
B678522213S0Tranquil-C™522213S2026-10-30
B678522214S0Tranquil-C™522214S2026-10-30
B678522215S0Tranquil-C™522215S2026-10-30
B678522216S0Tranquil-C™522216S2026-10-30
B6785222250Tranquil-C™5222252021-12-17
B6785222260Tranquil-C™5222262021-12-17
B6785222270Tranquil-C™5222272021-12-17
B6785222280Tranquil-C™5222282021-12-17
B6785222290Tranquil-C™5222292021-12-17
B6785222300Tranquil-C™5222302021-12-17
B6785222310Tranquil-C™5222312021-12-17
B6785222320Tranquil-C™5222322021-12-17
B6785222330Tranquil-C™5222332021-12-17
B6785222340Tranquil-C™5222342021-12-17
B6785222350Tranquil-C™5222352021-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841732169258MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
00841732169265MONET Anterior Cervical Interbody Fusion Cage System with Supplementary FixationCTL Medical CorporationOVE2026-11-02
08809974858424Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858431Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858448Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858455Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858462Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858479Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858486Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858493Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858509Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858516Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858523Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858530Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858547Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858554Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858561Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858578Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858585Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858592Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858608Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858615Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858622Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858639Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858646Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858653Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858660Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858677Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858684Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19
08809974858691Anyplus II Spinal Fixation SystemGS Medical Co., Ltd.MAX2025-12-19