DEVICE: SPIN (10381780047315)
Device Identifier (DI) Information
SPIN
112011ND
In Commercial Distribution
112011ND
NEWDEAL
112011ND
In Commercial Distribution
112011ND
NEWDEAL
The SPIN SNAP-OFF SCREW is a self drilling and self tapping snap-off screw. One part is fixed on a standard surgical power equipment and when the snap-off screw is totally introduced in the bone, its head is blocked and the breaking torque is important enough to cause dissociation between the screw and the snap-off. It comes in lengths from 11 to 14mm and it is available in 2.0mm and 2.7mm diameters. It is made from Titanium alloy and it is delivered non sterile.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
56642 | Orthopaedic bone screw, non-bioabsorbable, non-sterile |
A small, non-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). Screws available are: 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. This device must be sterilized prior to use.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dry place. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 2mm diam. x 11mm length |
Device Record Status
c69ba7f2-3799-4547-bb40-e44929b2e444
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 |
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HIBCC | M248112011ND1 |
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