FDA.reportPublic FDA data

DynaBunion

Primary DI
00850038154189
Brand
DynaBunion
Company
CROSSROADS EXTREMITY SYSTEMS
Model
1500-4801
Catalog number
1500-4801
Device description
The MotoBAND™ CP DynaForce® MPJ 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. Certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.
Published
2022-08-02
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

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850038154189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850038154189008500381541898500381541890850038154189

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-use, sterileA sterile, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592924TriLeap Lower Extremity Anatomic Plating System2.0 mm Ti Cortex Screw Length 13 mm, Blue04.901.0132024-02-21
00810112595758TriLeap Lower Extremity Anatomic Plating System1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, L04.900.0192024-02-16
00810112592443TriLeap Lower Extremity Anatomic Plating SystemLapidus Screw Targeting Guide Left03.900.3982024-02-23
00810112596748TriLeap Lower Extremity Anatomic Plating System04.900.146049001462026-02-13
00810112596779TriLeap Lower Extremity Anatomic Plating System04.900.149049001492026-02-13
00810112598063MOTOBAND InstrumentsVIRTUGUIDE 0 RAC ROTATION - 10° - RT380004R-NSPKG2024-08-01
00810112598421MOTOBAND InstrumentsVIRTUGUIDE 1 RAC ROTATION - 5° - LT380006L-NSPKG2024-08-01
00815432022878MotoBANDMotoBAND CP, Non-Locking Screw, 3.5mm x 18mm - Ste1500-35182016-04-26
00810112593839TriLeap Lower Extremity Anatomic Plating System3.0 mm Ti Variable Angle Screw Length 9 mm, Gold04.906.0092024-02-22
00810112594669TriLeap Lower Extremity Anatomic Plating System3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple04.909.0322024-02-22
00810112595871TriLeap Lower Extremity Anatomic Plating System1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, 04.900.0332024-02-16
00815432026241HiMAX C7115-1515-C7115-1515-C2022-01-04
00815432029563MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threa15FT-35342021-12-17
00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
00815432025459MotoBANDMotoBAND CP, Non-Locking Screw, 3mm x 28mm - Steri15NL-30282018-07-02
00815432026258HiMAX C7115-1818-C7115-1818-C2022-01-04
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27
00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
00815432028832MotoBANDImplant, 3.5mm x 38mm Anti-Drift Bolt15LP-35382020-05-27

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Primary DI, Brand, Company table
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