FDA.reportPublic FDA data

Tranquil-L™

Primary DI
B6788231360
Brand
Tranquil-L™
Company
NEXUS SPINE, L.L.C.
Model
823136
Device description
Fixed Small Hudson T-Handle, M8 Cap
Published
2022-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B6788231360PrimaryHIBCC0

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
028137605
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B6785209110PressON Pedicle Screw System5209112026-09-04
B6785209120PressON Pedicle Screw System5209122026-09-04
B6785209130PressON Pedicle Screw System5209132026-09-04
B6785209140PressON Pedicle Screw System5209142026-09-04
B6785209150PressON Pedicle Screw System5209152026-09-04
B6785209160PressON Pedicle Screw System5209162026-09-04
B6785209170PressON Pedicle Screw System5209172026-09-04
B6785209180PressON Pedicle Screw System5209182026-09-04
B6785209190PressON Pedicle Screw System5209192026-09-04
B6785209200PressON Pedicle Screw System5209202026-09-04
B6785209210PressON Pedicle Screw System5209212026-09-04
B6785209220PressON Pedicle Screw System5209222026-09-04
B6785209230PressON Pedicle Screw System5209232026-09-04
B6785209240PressON Pedicle Screw System5209242026-09-04
B6785209250PressON Pedicle Screw System5209252026-09-04
B6785209260PressON Pedicle Screw System5209262026-09-04
B6785209270PressON Pedicle Screw System5209272026-09-04
B6785209280PressON Pedicle Screw System5209282026-09-04
B6785209290PressON Pedicle Screw System5209292026-09-04
B6785209300PressON Pedicle Screw System5209302026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B707125355730300DUALX DUAL PORTAL DISPOSABLE KIT-30MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730400DUALX DUAL PORTAL DISPOSABLE KIT-40MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730500DUALX DUAL PORTAL DISPOSABLE KIT-50MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730600DUALX DUAL PORTAL DISPOSABLE KIT-60MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730800DUALX DUAL PORTAL DISPOSABLE KIT-80MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
00763000703929MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704100MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704117MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704124MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704131MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704148MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704155MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27
00763000704162MSB CAPSTONE CONTROL™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MAX2026-08-27