FDA.reportPublic FDA data

MotoBAND™ CP DynaForce®

Primary DI
00815432027187
Brand
MotoBAND™ CP DynaForce®
Company
CROSSROADS EXTREMITY SYSTEMS
Model
DynaForce Plate Sterile Instrument Kit
Catalog number
1500-4700
Device description
The MotoBAND™ CP DynaForce® Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. When used for these indications, certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.
Published
2019-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152306000MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC2015-12-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432027187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432027187008154320271878154320271870815432027187

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate bending insert, reusableA device that is inserted into the threaded or non-threaded hole of a metal orthopaedic fixation plate (e.g., trauma or craniofacial plate) prior to the surgeon bending the plate to conform to the anatomical shape of the implant site (e.g., jawbone or pelvis) in order to preserve the integrity of the holes which would otherwise deform, negating the entry of the bone screws that hold the plate in place. It is typically made of metal or synthetic material in the form of a short screw or pin-like device with a slotted head (for the acceptance of a screwdriver) used solely during the bending of plates that typically have a continuous row of screw holes. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
901-221-8406info@crextremity.com

Regulatory Flags#

DUNS number
058864308
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815432024322DynaForce MotoBAND Max7100-4H157100-4H152022-12-09
00815432024339DynaForce MotoBAND Max7100-4H187100-4H182022-12-09
00815432024353DynaForce MotoBAND Max7100-5H187100-5H182022-12-09
00815432024360DynaForce MotoBAND Max7100-99PN7100-99PN2022-12-09
00815432024377DynaForce MotoBAND Max7100-RD157100-RD152022-12-09
00815432024391DynaForce MotoBAND Max7100-RP157100-RP152022-12-09
00815432024407DynaForce MotoBAND Max7100-RP187100-RP182022-12-09
00815432024421DynaForce MotoBAND Max7100-TJ187100-TJ182022-12-09
00815432024438DynaForce MotoBAND Max7100-ZA157100-ZA152022-12-09
00815432027989MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018R2020-11-12
00815432027996MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018R2020-11-12
00815432028009MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020R2020-11-12
00815432028016MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020R2020-11-12
00815432028023MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018L2020-11-12
00815432028030MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018L2020-11-12
00815432028047MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020L2020-11-12
00815432028054MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020L2020-11-12
00815432028726MotoBANDImplant, 3.5mm x 28mm Anti-Drift Bolt15LP-35282020-05-27
00815432028795MotoBANDImplant, 3.5mm x 30mm Anti-Drift Bolt15LP-35302020-05-27
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23