FDA.reportPublic FDA data

MotoBAND CP

Primary DI
00815432029754
Brand
MotoBAND CP
Company
CROSSROADS EXTREMITY SYSTEMS
Model
Medial Column Staple Plate Left -18/15
Catalog number
7100-ML85
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
2022-01-04
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432029754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432029754008154320297548154320297540815432029754

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterileA sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145284PURE PECTUSKLS-Martin L.P.HRS2026-05-25
00888118145291PURE PECTUSKLS-Martin L.P.HRS2026-05-25
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftBonebridge AGHRS2026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightBonebridge AGHRS2026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftBonebridge AGHRS2026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightBonebridge AGHRS2026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftBonebridge AGHRS2026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightBonebridge AGHRS2026-05-22
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
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00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
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00888867535053Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535077Arthrex®ARTHREX, INC.HRS2026-02-23
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00888867535114Arthrex®ARTHREX, INC.HRS2026-02-23
00888867535138Arthrex®ARTHREX, INC.HRS2026-02-23