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Locking Proximal Femur Plate System

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
Locking Proximal Femur Plate System FDA UDI
Generic Name
Growth-correction orthopaedic fixation plate kit FDA UDI
Device Name
90 Deg x 4.5mm PLATE, 14mm OFFSET, 4 HOLE FDA UDI
Model / Reference
00-0907-1404 FDA UDI
Description
90 Deg x 4.5mm PLATE, 14mm OFFSET, 4 HOLE FDA UDI

Identifiers

Catalog Number
00-0907-1404 FDA UDI
Primary DI / UDI-DI
00841132104293 FDA UDI
510(k) Number
K111086 FDA UDI
FDA Product Code
HRS FDA UDI
GMDN Term
Growth-correction orthopaedic fixation plate kit 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

No

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

Category: Growth-correction orthopaedic fixation plate kit

Locking Proximal Femur Plate System by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Growth-correction orthopaedic fixation plate kit.

Cleared under the same submission

K111086 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI af108f7a-cbab-49ae-abbb-f4c159280eeb 36 fields · synced May 31, 2026