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Lever Action Plate System

FDA UDI

Class II (US FDA UDI)

by Mcginley Orthopaedic Innovations, Inc

Identity

Trade Name
Lever Action Plate System FDA UDI
Generic Name
Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name
K-WIRE .062 (1.6MM) X 4" LG FDA UDI
Model / Reference
0 FDA UDI
Description
K-WIRE .062 (1.6MM) X 4" LG FDA UDI

Identifiers

Catalog Number
MCGK4-062 FDA UDI
Primary DI / UDI-DI
B666MCGK40620 FDA UDI
510(k) Number
K200834 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Orthopaedic bone pin, non-bioabsorbable 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

No

FDA UDI

Manufacturing Date

No

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

Category: Orthopaedic bone pin, non-bioabsorbable

Lever Action Plate System by Mcginley Orthopaedic Innovations, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Cleared under the same submission

K200834 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mcginley Orthopaedic Innovations, Inc

Sources (1)

  • FDA UDI 0b8e4fa6-0983-486d-a218-91d2a41e0fbd 35 fields · synced Jun 8, 2026