MotoBAND™ CP DynaForce® MPJ Cup and Cone Reamer Kit, 14mm

Primary DI
00815432025930
Brand
MotoBAND™ CP DynaForce® MPJ Cup and Cone Reamer Kit, 14mm
Company
CROSSROADS EXTREMITY SYSTEMS
Model
70CC-0014
Catalog number
70CC-0014
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
2018-04-24
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTOReamerOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173710000MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC2018-02-12HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432025930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432025930008154320259308154320259300815432025930

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reprocessedA sterile, orthopaedic, surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a previously used single-use device that has been processed for an additional single-use patient application.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

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00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
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00815432026258HiMAX C7115-1818-C7115-1818-C2022-01-04
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00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
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