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FDA 510(k)

The Locking Pediatric Osteotomy Plate (LolliPOP) System

K-Number: K170704 · 2017-09-08

ApplicantPega Medical, Inc.
Decision Date2017-09-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

The Locking Pediatric Osteotomy Plate (LolliPOP) System is a medical device manufactured by Pega Medical, Inc.. It received FDA 510(k) clearance on 2017-09-08 under approval number K170704. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The Locking Pediatric Osteotomy Plate (LolliPOP) System?

The Locking Pediatric Osteotomy Plate (LolliPOP) System is a medical device that received FDA 510(k) clearance on 2017-09-08. It is manufactured by Pega Medical, Inc.. The 510(k) number is K170704.

When was The Locking Pediatric Osteotomy Plate (LolliPOP) System approved by the FDA?

The Locking Pediatric Osteotomy Plate (LolliPOP) System received FDA 510(k) clearance on 2017-09-08, under approval number K170704.

What company makes The Locking Pediatric Osteotomy Plate (LolliPOP) System?

The Locking Pediatric Osteotomy Plate (LolliPOP) System is manufactured by Pega Medical, Inc..

What is the FDA product code for The Locking Pediatric Osteotomy Plate (LolliPOP) System?

The FDA product code for The Locking Pediatric Osteotomy Plate (LolliPOP) System is KTT.

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Related PubMed Literature

PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Pega Medical, Inc.

K160545GAP ENDO-EXO MEDULLARY SYSTEM K163003Y3 Proximal Femoral Plate System K192710The Simple Locking Intramedullary (Slim) System K211292Fassier-Duval Telescopic IM System K220190The GIRO Growth Modulation System

Related Devices (Code: KTT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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