FDA.reportPublic FDA data

RetroFix

Primary DI
00850005757252
Brand
RetroFix
Company
RETROFIX SCREWS, LLC
Model
80L:PROX6-40L:DIST4 TI
Catalog number
CTM000758-025 TI
Device description
CANNULATED TAPERED SCREW OVERALL LENGTH 80MM PROXIMAL DIAMETER 6MMPROXIMAL LENGHT 40MMDISTAL DIAMETER 4MMMATERIAL: TI
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
00850005757252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005757252008500057572528500057572520850005757252

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-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). Screws available are: 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. This device must be sterilized prior to use.

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

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