FDA.reportPublic FDA data

CrossRoads Screw System

Primary DI
00850310006892
Brand
CrossRoads Screw System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
6.5 Headed Implant Prep Kit Including Reamer
Catalog number
1456-6565
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
00850310006892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850310006892008503100068928503100068920850310006892

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, single-useA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.

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

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