FDA.reportPublic FDA data

MotoBAND

Primary DI
00815432027798
Brand
MotoBAND
Company
CROSSROADS EXTREMITY SYSTEMS
Model
H10 Self Retaining Driver
Catalog number
1500-5050
Device description
The MotoBAND™ CP 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.
Published
2019-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWRDriver, Prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432027798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432027798008154320277988154320277980815432027798

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-useA non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(901)221-8406info@crextremity.com

Regulatory Flags#

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
true
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
00810112599268TriLEAP1st MTP Ti Fusion Plate, Extra Small, 6 Hole, 10 D04.900.2502025-03-17
00810112593341TriLeap Lower Extremity Anatomic Plating System2.5 mm Ti Cortex Screw Length 30 mm, Magenta04.903.0302024-02-22
00810112592320TriLeap Lower Extremity Anatomic Plating System26MM Cannulated Cone Reamer03.900.3922024-02-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024715196T6 Driver 127mm AO QCZimmer, Inc.HWR2026-10-19
00889024715202T8 Driver 127mm AO QCZimmer, Inc.HWR2026-10-19
10705034579955N/AMedos International SàrlHWR2026-10-06
00889024712904RMR LONG KEYZimmer, Inc.HWR2026-08-25
00889024712911X BAR RMR ADPT TALLZimmer, Inc.HWR2026-08-25
00889024712928RMR SHORT KEYZimmer, Inc.HWR2026-08-25
00889024712935RMR SHORT KEY BENTZimmer, Inc.HWR2026-08-25
00889024712942RMR LONG KEY BENTZimmer, Inc.HWR2026-08-25
03701089545358AMPLITUDEAMPLITUDE SASHWR2026-07-29
03701089545365AMPLITUDEAMPLITUDE SASHWR2026-07-29
08809926260299InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260312InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260329InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260336InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260343InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260350InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260367InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260374InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260381InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260398InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260404InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
00810112597967DynaForceCROSSROADS EXTREMITY SYSTEMSHWR2024-08-07
00810112597950MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHWR2024-08-01
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03