DynaFORCE Staple Instruments

Primary DI
00810112597820
Brand
DynaFORCE Staple Instruments
Company
CROSSROADS EXTREMITY SYSTEMS
Model
MOTOCLIP INSERTER ASSEMBLY, 10X10
Catalog number
100024PKG
Device description
MOTOCLIP INSERTER ASSEMBLY, 10X10
Published
2024-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142727000CrossCLIP Implant SystemOrthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems2014-10-24JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112597820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112597820008101125978208101125978200810112597820

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
00815432028108DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2022-10-24
00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432026258HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
B56217634WB0Memory StapleWishbone Medical, Inc.JDR2020-08-06
00815432027255DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-06-03
00815432026111DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026128DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026135HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026142HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026180HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026197HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026203HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026326DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026340HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028788MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028726MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028795MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028801MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028818MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028184DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432028221DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432027279DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027286DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028115DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028122DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028139DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028146DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028153DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028160DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028177DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20