DEVICE: CurvaFix® IM Implant (10855068008102)
Device Identifier (DI) Information
CurvaFix® IM Implant
9.5 MM x 210 MM, Self Tapping
In Commercial Distribution
CRS-095-210-02
Curvafix Inc
9.5 MM x 210 MM, Self Tapping
In Commercial Distribution
CRS-095-210-02
Curvafix Inc
The CurvaFix® IM Implant is an implantable intramedullary device for the fixation of pelvic fractures. It has a threaded, self-tapping distal end, and a proximal end feature for driving torque, and a lock feature that changes the IM Implant from a flexible to rigid state during implantation. The device is manufactured from Stainless Steel.
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
44854 | Arthrodesis intramedullary nail, non-distracting |
A rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.
|
Active | true |
46646 | 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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HSB | Rod, Fixation, Intramedullary And Accessories |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K180050 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 9.5 Millimeter |
Length: 210 Millimeter |
Device Record Status
bc10165e-493d-4b06-b033-3cd618079173
February 06, 2025
5
August 11, 2021
February 06, 2025
5
August 11, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
425-276-8800
support@curvafix.com
support@curvafix.com