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The Locking Pediatric Osteotomy Plate (LolliPOP) System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref POP-LS27-12Model LOCKING SCREW

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
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
Locking Screw, Ø2.7 X 12mm FDA UDI
Model / Reference
POP-LS27-12 EUDAMEDFDA UDI
LOCKING SCREW EUDAMED
Description
Locking Screw, Ø2.7 X 12mm FDA UDI

Identifiers

Catalog Number
POP-LS27-12 FDA UDI
Primary DI / UDI-DI
07540194006684 EUDAMEDFDA UDI
Basic UDI-DI
7540194POP-SCW2Y EUDAMED
510(k) Number
K170704 FDA UDI
FDA Product Code
KTT FDA UDI
EMDN Code
P09120601 CORTICAL SCREWS EUDAMED
GMDN Term
Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Sutures

Yes

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

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 — 12 Millimeter FDA UDI
Outer Diameter — 2.7 Millimeter FDA UDI

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

Cleared under the same submission

K170704 also covers:

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 5ace8640-1db1-4628-95d3-43e77ed48630 38 fields · synced Oct 7, 2026
  • EUDAMED 7b7de612-7b5a-4a84-b0fd-ad8d4607dd37 61 fields · synced Jul 12, 2026