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Monkey Bars™ Pin to Bar External Fixation System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name
Monkey Bars™ Pin to Bar External Fixation System FDA UDI
Generic Name
Pin-sleeve orthopaedic bone screw FDA UDI
Device Name
5mm Pin Cap (10 Pack) FDA UDI
Model / Reference
P47-230-0525 FDA UDI
Description
5mm Pin Cap (10 Pack) FDA UDI

Identifiers

Catalog Number
P47-230-0525 FDA UDI
Primary DI / UDI-DI
00889795114709 FDA UDI
510(k) Number
K211112 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
Pin-sleeve orthopaedic bone screw FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Pin-sleeve orthopaedic bone screw

Monkey Bars™ Pin to Bar External Fixation System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pin-sleeve orthopaedic bone screw.

Cleared under the same submission

K211112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Paragon 28

Sources (1)

  • FDA UDI 3602cff4-eeae-4896-aa48-b9a2b26d8dd9 35 fields · synced May 30, 2026