FDA.reportPublic FDA data

MOTOBAND CP

Primary DI
00810112592115
Brand
MOTOBAND CP
Company
CROSSROADS EXTREMITY SYSTEMS
Model
30° IM - 40° FP Right- 3D Correction Pin Guide
Catalog number
TG03-040R
Device description
The MotoBAND™ CP Implant System includes DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion System, which include plates and screws 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. DynaBunion™ 4D Minimal-incision Bunion System and DynaMet™ Lesser TMT Fusion plates are compatible with fracture fixation staples from the MotoCLIP™/HiMAX™ Implant System cleared in K142727, K181410 and K193452
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00810112592115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112592115008101125921158101125921150810112592115

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00810112596793TriLeap Lower Extremity Anatomic Plating System04.900.151049001512026-02-19
00810112597202TriLeap Lower Extremity Anatomic Plating System04.913.035049130352026-02-19
00810112597219TriLeap Lower Extremity Anatomic Plating System04.913.040049130402026-02-19
00810112597226TriLeap Lower Extremity Anatomic Plating System04.913.045049130452026-02-19
00810112597233TriLeap Lower Extremity Anatomic Plating System04.913.050049130502026-02-19
00810112597240TriLeap Lower Extremity Anatomic Plating System04.913.055049130552026-02-19
00810112597257TriLeap Lower Extremity Anatomic Plating System04.913.060049130602026-02-19
00810112597264TriLeap Lower Extremity Anatomic Plating System04.913.065049130652026-02-19
00810112597271TriLeap Lower Extremity Anatomic Plating System04.914.035049140352026-02-19
00810112597288TriLeap Lower Extremity Anatomic Plating System04.914.040049140402026-02-19
00810112597295TriLeap Lower Extremity Anatomic Plating System04.914.050049140502026-02-19
00810112597301TriLeap Lower Extremity Anatomic Plating System04.914.045049140452026-02-19
00810112597318TriLeap Lower Extremity Anatomic Plating System04.914.055049140552026-02-19
00810112597325TriLeap Lower Extremity Anatomic Plating System04.914.060049140602026-02-19
00810112597332TriLeap Lower Extremity Anatomic Plating System04.914.065049140652026-02-19
00810112598933TriLeap Lower Extremity Anatomic Plating System04.900.118049001182026-02-19
00810112598940TriLeap Lower Extremity Anatomic Plating System04.900.119049001192026-02-19
00810112598957TriLeap Lower Extremity Anatomic Plating System04.900.120049001202026-02-19
00810112598964TriLeap Lower Extremity Anatomic Plating System04.900.121049001212026-02-19
00810112598971TriLeap Lower Extremity Anatomic Plating System04.900.122049001222026-02-19

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