FDA.reportPublic FDA data

DartFire Edge

Primary DI
00889797084710
Brand
DartFire Edge
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
D0240018
Catalog number
D0240018
Device description
Cannulated Screw
Published
2022-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K203228000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203228000DART-FIRE EDGE Cannulated Screw SystemWright Medical2021-05-11HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797084710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797084710008897970847108897970847100889797084710

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
Length18Millimeter
Outer Diameter4Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889797069298INVISION™60006027600060272022-11-16
00889797103619PROSTEP™ MICA™57790001577900012022-02-01
00889797080392PRO-DENSE LoVisc87SRLV0587SRLV052023-11-21
00889797080415PRO-DENSE LoVisc87SRLV1087SRLV102023-11-21
00889797103589PRO-DENSE LoVisc87SRLV2087SRLV202023-11-21
00889797109796PRO-DENSE LoVisc1420LVGA1420LVGA2023-11-21
00889797076005MINI IGNITE 2.0876P0020876P00202022-08-23
00889797076012MINI IGNITE 2.0876P0040876P00402022-08-23
00889797076036IGNITE 2.0876P0200876P02002022-08-23
00889797076029IGNITE™ 2.0876P0080876P00802022-02-24
00889797072700PRO-DENSE™87SR015087SR01502020-09-08
00889797072717PRO-DENSE™87SR040087SR04002020-09-08
00889797072724PRO-DENSE™87SRCDK087SRCDK02020-09-08
00889797072748PRO-DENSE™87SR002087SR00202020-09-08
00889797072755PRO-DENSE™87SR005087SR00502020-09-08
00889797072762PRO-DENSE™87SR010087SR01002020-09-08
00889797073301PRO-DENSE™87SR007087SR00702020-09-08
00889797073318PRO-DENSE™87SR012087SR01202020-09-08
00840420133434OSTEOSET84000211840002112015-10-15
00840420133465OSTEOSET84000305840003052015-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894821714APTUSMedartis AGHWC2026-10-27
07630894821721APTUSMedartis AGHWC2026-10-27
07630894821738APTUSMedartis AGHWC2026-10-27
07630894821745APTUSMedartis AGHWC2026-10-27
07630894821752APTUSMedartis AGHWC2026-10-27
07630894821769APTUSMedartis AGHWC2026-10-27
07630894821776APTUSMedartis AGHWC2026-10-27
07630894821783APTUSMedartis AGHWC2026-10-27
07630894821790APTUSMedartis AGHWC2026-10-27
07630894821806APTUSMedartis AGHWC2026-10-27
07630894821813APTUSMedartis AGHWC2026-10-27
07630894821820APTUSMedartis AGHWC2026-10-27
07630894821837APTUSMedartis AGHWC2026-10-27
07630894821851APTUSMedartis AGHWC2026-10-27
07630894821875APTUSMedartis AGHWC2026-10-27
07630894821899APTUSMedartis AGHWC2026-10-27
07630894821912APTUSMedartis AGHWC2026-10-27
07630894821936APTUSMedartis AGHWC2026-10-27
07630894821950APTUSMedartis AGHWC2026-10-27
07630894821974APTUSMedartis AGHWC2026-10-27
07630894821998APTUSMedartis AGHWC2026-10-27
07630894822018APTUSMedartis AGHWC2026-10-27
07630894822032APTUSMedartis AGHWC2026-10-27
07630894822056APTUSMedartis AGHWC2026-10-27
07630894822070APTUSMedartis AGHWC2026-10-27
07630894822094APTUSMedartis AGHWC2026-10-27
07630894822117APTUSMedartis AGHWC2026-10-27
07630894822131APTUSMedartis AGHWC2026-10-27
07630894822155APTUSMedartis AGHWC2026-10-27
07630894822179APTUSMedartis AGHWC2026-10-27