FDA.reportPublic FDA data

iFix®

Primary DI
M543CM1230
Brand
iFix®
Company
CAYENNE MEDICAL, INC.
Model
CM-1230
Device description
iFix™ Interference Screw - 12mm x 30mm
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K073426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073426000APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MMCayenne Medical, Inc.2008-02-19HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M543CM1230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterile"A 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."

Regulatory Flags#

DUNS number
606719685
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
M543CM8010Quattro®CM-8010CM-80102019-03-29
M543CM6127BioWick SureLockCM-61272016-01-10
M543CM6255BioWick XCM-62552018-01-31
M543CM6265BioWick XCM-62652018-01-25
00887868269769BioWick® SureLock®CM-61272020-09-21
00887868269790BioWick® XCM-62552020-09-21
00887868269813BioWick® XCM-62652020-09-21
M5431100259901Ventix™1100259901100259902018-12-04
M5431100259921Ventix™1100259921100259922018-12-04
M543CM1025iFix®CM-10252015-10-09
M543CM1030iFix®CM-10302015-10-09
M543CM1130iFix®CM-11302015-10-09
M543CM1720iFix®CM-17202015-10-09
M543CM1725iFix®CM-17252015-10-09
M543CM1820iFix®CM-18202015-10-09
M543CM1825iFix®CM-18252015-10-09
M543CM1830iFix®CM-18302015-10-09
M543CM1920iFix®CM-19202015-10-09
M543CM1925iFix®CM-19252015-10-09
M543CM1930iFix®CM-19302015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09353903015383NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
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09353903015444NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
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09353903015482NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015499NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015505NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
09353903015512NX Nail SystemFIELD ORTHOPAEDICS PTY LTDHWC2023-07-16
00850051329038Sternalock EZJACE MEDICAL, LLCHWC2023-05-26
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00885556838327Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00885556824764DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824771DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824788DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824795DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824818DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824825DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556835043Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835050Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22