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The Locking Pediatric Osteotomy Plate (LolliPOP) System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref POP-CVL-130Model PLATE
Identity
- Trade Name
- The Locking Pediatric Osteotomy Plate system EUDAMEDThe Locking Pediatric Osteotomy Plate (LolliPOP) System FDA UDI
- Generic Name
- Femoral fixation plate/blade FDA UDI
- Device Name
- Valgus Plate, Child 130° FDA UDI
- Model / Reference
- POP-CVL-130 EUDAMEDFDA UDIPLATE EUDAMED
- Description
- Valgus Plate, Child 130° FDA UDI
Identifiers
- Catalog Number
- POP-CVL-130 FDA UDI
- Primary DI / UDI-DI
- 07540194005328 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194POP-PLT36 EUDAMED
- 510(k) Number
- K170704 FDA UDI
- FDA Product Code
- KTT FDA UDI
- EMDN Code
- P09120504 OSTEOSYNTHESIS BLADE-PLATE SYSTEMS EUDAMED
- GMDN Term
- Femoral fixation plate/blade FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 130 degree 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:
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
- The Locking Pediatric Osteotomy Plate (LolliPOP) System — Orthopediatrics Canada ULC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 1c6fb9dc-7df0-45d6-b301-5f620f55691f 38 fields · synced Oct 7, 2026
- EUDAMED 4c5b63f1-268d-4d5c-94fa-63bb2e1782b1 61 fields · synced Jul 12, 2026