DEVICE: RONDO' (08032909622368)
Device Identifier (DI) Information
RONDO'
Screw ø4mm L28mm
In Commercial Distribution
VP-14028
CITIEFFE SRL
Screw ø4mm L28mm
In Commercial Distribution
VP-14028
CITIEFFE SRL
Titanium cannulated screw ø4mm L28mm with washer.
Material: titanium alloy Ti6Al4V ELI (ASTM F136).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
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.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HTY | Pin, Fixation, Smooth |
HTN | Washer, Bolt Nut |
HWC | Screw, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K113388 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Dry and clean environment and avoid damaging the packing. Room temperature. |
Clinically Relevant Size
[?]Size Type Text |
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Length: 28 Millimeter |
Outer Diameter: 4 Millimeter |
Device Record Status
cb9244c7-dd42-44d1-88ec-151a893ea49b
February 19, 2024
4
October 21, 2015
February 19, 2024
4
October 21, 2015
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
[?]
+39051721850
info@citieffe.com
info@citieffe.com