FDA.reportPublic FDA data

CrossRoads Screw System

Primary DI
00850310006854
Brand
CrossRoads Screw System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
3.0 Headed Implant Prep Kit Including Reamer
Catalog number
1456-3030
Device description
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
Published
2016-03-07
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
HWCScrew, Fixation, Bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143039000CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015-01-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850310006854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850310006854008503100068548503100068540850310006854

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA sterile surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

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00810112598063MOTOBAND InstrumentsVIRTUGUIDE 0 RAC ROTATION - 10° - RT380004R-NSPKG2024-08-01
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00815432022878MotoBANDMotoBAND CP, Non-Locking Screw, 3.5mm x 18mm - Ste1500-35182016-04-26
00810112593839TriLeap Lower Extremity Anatomic Plating System3.0 mm Ti Variable Angle Screw Length 9 mm, Gold04.906.0092024-02-22
00810112594669TriLeap Lower Extremity Anatomic Plating System3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple04.909.0322024-02-22
00810112595871TriLeap Lower Extremity Anatomic Plating System1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, 04.900.0332024-02-16
00815432026241HiMAX C7115-1515-C7115-1515-C2022-01-04
00815432029563MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threa15FT-35342021-12-17
00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
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
00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
00815432028832MotoBANDImplant, 3.5mm x 38mm Anti-Drift Bolt15LP-35382020-05-27

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