FDA.reportPublic FDA data

Mobi-C Plug & Fit US

Primary DI
03662663059152
Brand
Mobi-C Plug & Fit US
Company
LDR Spine Usa, Inc.
Model
MB9101R
Device description
Slim Mobi-C No Touch Implant Holder
Published
2024-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QLQManual Instruments Designed For Use With Total Disc Replacement Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLQManual Instruments Designed For Use With Total Disc Replacement DevicesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663059152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663059152036626630591523662663059152

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
615789729
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663000369Mobi-CMB942RMB942R2018-12-12
03662663002899Avenue TAT9033RAT9033R2017-04-12
03662663002912Avenue TAT9035RAT9035R2017-04-12
03662663033039VFTVF9004RVF9004R2017-05-19
03662663033169VFTVF9105RVF9105R2017-05-19
03662663036863EasyspineES9038RES9038R2018-12-11
03662663037402InterBRIDGEIB9003RIB9003R2018-12-12
03662663041447ROI-TIR9098RIR9098R2018-12-12
03662663041676ROI-AIR9202RIR9202R2017-03-23
03662663043076ROI-AIR9431RIR9431R2018-12-12
03662663043083ROI-AIR9432RIR9432R2018-12-12
03662663043175ROI-CMC9002RMC9002R2017-03-23
03662663043182ROI-CMC9003RMC9003R2017-03-23
03662663043632MC+MC908RMC908R2018-12-11
03662663043656ROI-CMC9092RMC9092R2017-03-23
03662663043663ROI-CMC9093RMC9093R2017-03-23
03662663043670ROI-CMC9094RMC9094R2017-03-23
03662663044165MC+MC937RMC937R2018-12-11
03662663044172MC+MC938RMC938R2018-12-11
03662663044332MC+MC960RMC960R2018-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843193111838Prodisc L InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112323Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112330Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112347Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112354Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193112361Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119926Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119933Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119940Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119957Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119964Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119971Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119988Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193119995Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
00843193120007Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLCQLQ2026-06-08
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M670910000021205Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021407Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M670910000021609Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
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M670910000080109Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000008020Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009150Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009160Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17
M67091000009250Synergy Disc InstrumentsSynergy Spine Solutions IncQLQ2026-04-17