FDA.reportPublic FDA data

RetroFix

Primary DI
00850005757658
Brand
RetroFix
Company
RETROFIX SCREWS, LLC
Model
K-Wire, 1.3mm x 300mm PK 25
Catalog number
CTM001055
Device description
Surgical K-WireKirshner wire or pinsGuide Wire1.3mm Diameter 300 mm Length
Published
2020-12-30
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
00850005757658PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005757658008500057576588500057576580850005757658

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
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
00850005757078RetroFix 80L:PROX5-35L:DIST4 TICTM000758-007 TI2020-12-23

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