DEVICE: SNAP-OFF (10381780047568)
Device Identifier (DI) Information
SNAP-OFF
117018SND
In Commercial Distribution
117018SND
NEWDEAL
117018SND
In Commercial Distribution
117018SND
NEWDEAL
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
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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 |
---|---|
HRS | PLATE, FIXATION, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K052152 | 000 |
K093781 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in dry place. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 2.7mm diam. x 18mm length |
Device Record Status
29a0a5e1-48f4-4b44-8c18-88232dda0b76
February 19, 2024
6
October 09, 2017
February 19, 2024
6
October 09, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M248117018SND1 |
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
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com