AccessGUDID - DEVICE: Piccolo Composite Nailing System (07290109332697)

GUDID

Device Identifier (DI) Information

Brand Name: Piccolo Composite Nailing System
Version or Model: Ankle Arthrodesis Nail
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PAAN10160
Company Name: CARBOFIX ORTHOPEDICS LTD

Primary DI Number: 07290109332697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 649185170 *Terms of Use

Device Description: An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative arthritis; Severe defects after tumor resection; Pantalar arthrodesis

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?
44854	Arthrodesis nail, fixed-length	A rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123810	000
K132774	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
Outer Diameter: 10 Millimeter
Length: 160 Millimeter
Device Size Text, specify: Proximal Diameter: 12 Millimeter

Device Record Status

Public Device Record Key: ae36df85-635d-4146-9cff-50c4f8438dea
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: October 15, 2015