DEVICE: Piccolo Composite Plate System (07290109333946)

Device Identifier (DI) Information

Piccolo Composite Plate System
Locking Screw
In Commercial Distribution
PRTST3518
CARBOFIX ORTHOPEDICS LTD
07290109333946
GS1

1
649185170 *Terms of Use
Locking screw for use with distal volar radius plate
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, Fixation, Bone
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102597 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 3.5 Millimeter
Length: 18 Millimeter
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Device Record Status

0792f3bd-b247-4670-bd5b-5e3083fde915
July 06, 2018
3
October 18, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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