AccessGUDID - DEVICE: Monkey Bars™ Pin to Bar External Fixation System (00889795114709)

GUDID

Device Identifier (DI) Information

Brand Name: Monkey Bars™ Pin to Bar External Fixation System
Version or Model: P47-230-0525
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P47-230-0525
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795114709
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: 5mm Pin Cap (10 Pack)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
58959	Pin-sleeve orthopaedic bone screw	An implantable device comprising a small, threaded, cannulated sleeve containing a pin fixed inside at its distal end, intended to be used to hold a bone plate in place for internal orthopaedic fracture fixation. It is anchored to bone by the external thread on the sleeve and to the fixation plate by the thread on the head of the pin. It is intended to provide compression of the fracture site and to allow micro-movement for even distribution of load across the fixation plate to promote symmetrical callus formation. It is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)]. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211112	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3602cff4-eeae-4896-aa48-b9a2b26d8dd9
Public Version Date: September 23, 2025
Public Version Number: 4
DI Record Publish Date: September 14, 2022