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The Locking Pediatric Osteotomy Plate (LolliPOP) System

FDA UDIEUDAMED

Class II (US FDA UDI)

by Orthopediatrics Canada ULC

Identity

Trade Name
The Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
Generic Name
Femoral fixation plate/blade FDA UDI
Device Name
Blade, Infant 35mm FDA UDI
Model / Reference
POP-IB-35 FDA UDI
Description
Blade, Infant 35mm FDA UDI

Identifiers

Catalog Number
POP-IB-35 FDA UDI
Primary DI / UDI-DI
07540194005700 FDA UDI
510(k) Number
K170704 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
Femoral fixation plate/blade 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

Dimensions & Sizes

Size
Length — 35 Millimeter FDA UDI

Category: Femoral fixation plate/blade

The Locking Pediatric Osteotomy Plate (LolliPOP) System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Femoral fixation plate/blade.

Cleared under the same submission

K170704 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Canada ULC

Sources (2)

  • FDA UDI d774db23-e567-42e6-ab9c-6223f82232c9 38 fields · synced Jun 20, 2026
  • EUDAMED 1 fields · synced May 28, 2026