FDA.reportPublic FDA data

RetroFix

Primary DI
00850005757757
Brand
RetroFix
Company
RETROFIX SCREWS, LLC
Model
K-Wire, 1.3mm x 225mm PK 1
Catalog number
CTM000882
Device description
Surgical K-WireKirshner wire or pinsGuide Wire1.3mm Diameter 225mm Length
Published
2020-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K200226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200226000RetroFixRetrofix Screws, LLC2020-06-26HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005757757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005757757008500057577578500057577570850005757757

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
19804328412tmiller@retrofixscrews.com

Regulatory Flags#

DUNS number
069485021
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005757030RetroFix 80L:PROX5-25L:DIST4 TICTM000758-003 TI2020-12-30
00850005757047RetroFix 80L:PROX5-30L:DIST4.5 TICTM000758-004 TI2020-12-30
00850005757092RetroFix 80L:PROX5-40L:DIST4 TICTM000758-009 TI2020-12-30
00850005757184RetroFix 80L:PROX6-25L:DIST4.5 TI CTM000758-018 TI2020-12-30
00850005757191RetroFix 80L:PROX6-25L:DIST4 TI CTM000758-019 TI2020-12-30
00850005757269RetroFix 90L:PROX5-25L:DIST4.5 TI CTM000758-026 TI2020-12-30
00850005757306RetroFix 90L:PROX5-40L:DIST4.5 TI CTM000758-030 TI2020-12-30
00850005757399RetroFix 90L:PROX6-25L:DIST4 TI CTM000758-039 TI2020-12-30
00850005757412RetroFix 90L:PROX6-30L:DIST4 TI CTM000758-041 TI2020-12-30
00850005757429RetroFix 90L:PROX6-40L:DIST4.5 TI CTM000758-042 TI2020-12-30
00850005757450RetroFix 100L:PROX5-30L:DIST4 TI CTM000758-045 TI2020-12-30
00850005757528RetroFix 110L:PROX5.5-30L:DIST4 TI CTM000758-052 TI2020-12-30
00850005757542RetroFix 110L:PROX5.5-25L:DIST4.5 TI CTM000758-054 TI2020-12-30
00850005757597RetroFix 110L:PROX6-40L:DIST4 TI CTM000758-059 TI2020-12-30
00850005757641RetroFix K-Wire, 1.3mm x 225mm PK 25CTM0008822020-12-30
00850005757658RetroFix K-Wire, 1.3mm x 300mm PK 25CTM0010552020-12-30
00850005757016RetroFix 80L:PROX5-20L:DIST4 TI CTM000758-001 TI2020-12-23
00850005757023RetroFix 80L:PROX5-25L:DIST4.5 TI CTM000758-002 TI2020-12-23
00850005757054RetroFix 80L:PROX5-30L:DIST4 TICTM000758-005 TI2020-12-23
00850005757061RetroFix 80L:PROX5-35L:DIST4.5 TICTM000758-006 TI2020-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01