FDA.reportPublic FDA data

RetroFix

Primary DI
00850005757665
Brand
RetroFix
Company
RETROFIX SCREWS, LLC
Model
Drill Guide
Catalog number
CTM000886
Device description
Tissue Protector Drill Guide4.0mm and 5.0mm
Published
2020-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850005757665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005757665008500057576658500057576650850005757665

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable 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
07613154320271MATTAStryker GmbHHWC2023-10-20
07613154320295MATTAStryker GmbHHWC2023-10-20
07613154320301MATTAStryker GmbHHWC2023-10-20
07613154320318MATTAStryker GmbHHWC2023-10-20
07613154320424MATTAStryker GmbHHWC2023-10-20
07613154320431MATTAStryker GmbHHWC2023-10-20
07613154320448MATTAStryker GmbHHWC2023-10-20
07613154320462MATTAStryker GmbHHWC2023-10-20
07613154320486MATTAStryker GmbHHWC2023-10-20
07613154320493MATTAStryker GmbHHWC2023-10-20
07613154320509MATTAStryker GmbHHWC2023-10-20
07613154320523MATTAStryker GmbHHWC2023-10-20
07613154320554MATTAStryker GmbHHWC2023-10-20
07613154320592MATTAStryker GmbHHWC2023-10-20
07613154320615MATTAStryker GmbHHWC2023-10-20
07613154320639MATTAStryker GmbHHWC2023-10-20
07613154320646MATTAStryker GmbHHWC2023-10-20
07613154320660MATTAStryker GmbHHWC2023-10-20
07613154320684MATTAStryker GmbHHWC2023-10-20
07613154320691MATTAStryker GmbHHWC2023-10-20
07613154320769MATTAStryker GmbHHWC2023-10-20
07613154320776MATTAStryker GmbHHWC2023-10-20
07613154320820MATTAStryker GmbHHWC2023-10-20
07613154320837MATTAStryker GmbHHWC2023-10-20
07613154320844MATTAStryker GmbHHWC2023-10-20
07613154320851MATTAStryker GmbHHWC2023-10-20
07613154320868MATTAStryker GmbHHWC2023-10-20
07613154320875MATTAStryker GmbHHWC2023-10-20
07613154320899MATTAStryker GmbHHWC2023-10-20
07613154320912MATTAStryker GmbHHWC2023-10-20