AccessGUDID - DEVICE: Piccolo Composite Plate System (07290109334325)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Plate System
Version or Model: Distal Fibula Plate
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PDFRN2009
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109334325
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: A plate indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, including in osteopenic bone.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46647	Orthopaedic fixation plate, non-bioabsorbable	A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
HRS	Plate, Fixation, Bone
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120409	000
K130061	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 155 Millimeter
Device Size Text, specify: Number of Shaft Holes: 9
Device Size Text, specify: Right/Left: R

Device Record Status

Public Device Record Key: 6ae7ec0b-5b7c-477c-a038-b6ca6cdaf436
Public Version Date: November 20, 2025
Public Version Number: 6
DI Record Publish Date: October 18, 2015