DEVICE: Piccolo Composite Plate System (07290109339429)

Device Identifier (DI) Information

Piccolo Composite Plate System
Template - 9H Right
In Commercial Distribution
PLRF0390
CARBOFIX ORTHOPEDICS LTD
07290109339429
GS1

1
649185170 *Terms of Use
Template for use with the Piccolo Composite Distal Fibula Plate System
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Surgical implant template, reusable A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.
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FDA Product Code

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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 [?]
K120409 000
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

75f32baa-5eb4-40a6-b5ba-63bc5f6062da
July 06, 2018
4
September 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

[?]
+97299511511
info@carbo-fix.com
1-800-408-0120
usa@carbo-fix.com
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