FDA.reportPublic FDA data

CrossRoads™ Bone Screw

Primary DI
00815432021710
Brand
CrossRoads™ Bone Screw
Company
CROSSROADS EXTREMITY SYSTEMS
Model
Headed
Catalog number
1406-6589
Device description
CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
Published
2016-01-12
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152072000CrossRoads Screw SystemCrossroads Extremity Systems, LLC2015-09-23HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432021710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432021710008154320217108154320217100815432021710

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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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
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00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
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