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The Locking Pediatric Osteotomy Plate (LolliPOP) System

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref POP-DCS127Model CORTICAL DRILL

by Orthopediatrics Canada ULC

Identity

Trade Name
The Locking Pediatric Osteotomy Plate system EUDAMED
The Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
Generic Name
Fluted surgical drill bit, reusable FDA UDI
Device Name
Ø2.0mm CORTICAL DRILL FOR Ø2.7mm SCREWS FDA UDI
Model / Reference
POP-DCS127 EUDAMEDFDA UDI
CORTICAL DRILL EUDAMED
Description
Ø2.0mm CORTICAL DRILL FOR Ø2.7mm SCREWS FDA UDI

Identifiers

Catalog Number
POP-DCS127 FDA UDI
Primary DI / UDI-DI
07540194008954 EUDAMEDFDA UDI
Basic UDI-DI
7540194POP-DRWY EUDAMED
FDA Product Code
HTW FDA UDI
EMDN Code
Z12130503 ORTHOPAEDIC SURGICAL DRILLS EUDAMED
GMDN Term
Fluted surgical drill bit, reusable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

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

Yes

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 — 220 Millimeter FDA UDI
Outer Diameter — 2 Millimeter FDA UDI

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Canada ULC

Sources (2)

  • FDA UDI 84c6c908-4372-4b4f-ae97-790459f251cc 37 fields · synced Oct 7, 2026
  • EUDAMED 1309425e-9c60-465a-abfa-bdc06961a011 61 fields · synced Jul 16, 2026