The Locking Pediatric Osteotomy Plate (LolliPOP) System

Polyaxial Compression Screw, Ø4.5 X 18mm

Registry build 21.09.26
17manufacturers in China registered for this device type
144catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KTT
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Hangzhou Sino-MIM Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 6
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5

Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Record

Regulatory record for The Locking Pediatric Osteotomy Plate (LolliPOP) System
Listed by Orthopediatrics Canada ULC, Canada
FDA product code KTT
Device type Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class Class 2
Regulation 21 CFR 888.3030
Establishment Manufacturer
510(k) K170704
Record published 2017-11-03
Record revised 2025-05-13 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
Storage Special storage condition: keep at room temperature
Sizes Length 12 to 70 mm; outer diameter 2.7 to 4.5 mm; angle 90 to 140 °
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for The Locking Pediatric Osteotomy Plate (LolliPOP) System
Catalogue number Size Status
POP-CB-35 Length 35 mm In distribution
POP-AVR-100 Angle 100 ° In distribution
POP-LS35-24 Length 24 mm In distribution
POP-CVL-130 Angle 130 ° In distribution
POP-CB-40 Length 40 mm In distribution
POP-HVR-100 Angle 100 ° In distribution
POP-LS27-20 Outer Diameter 2.7 mm In distribution
POP-OB45-18 Outer Diameter 4.5 mm In distribution
POP-LS27-12 Length 12 mm In distribution
POP-LS45-16 Outer Diameter 4.5 mm In distribution
POP-OB27-16 Outer Diameter 2.7 mm In distribution
POP-OB27-52 Length 52 mm In distribution
POP-LS45-26 Outer Diameter 4.5 mm In distribution
POP-CVL-120 Angle 120 ° In distribution
POP-LS27-40 Length 40 mm In distribution
POP-CVL-140 Angle 140 ° In distribution
POP-OB27-18 Outer Diameter 2.7 mm In distribution
POP-LS27-24 Length 24 mm In distribution
POP-LS27-16 Outer Diameter 2.7 mm In distribution
POP-OB35-12 Length 12 mm In distribution
POP-OB35-18 Outer Diameter 3.5 mm In distribution
POP-LS45-18 Outer Diameter 4.5 mm In distribution
POP-LS35-22 Length 22 mm In distribution
POP-OB35-16 Length 16 mm In distribution
POP-OB27-44 Outer Diameter 2.7 mm In distribution
POP-HVL-130 Angle 130 ° In distribution
POP-OB45-56 Outer Diameter 4.5 mm In distribution
POP-OB35-26 Outer Diameter 3.5 mm In distribution
POP-OB45-36 Length 36 mm In distribution
POP-OB27-22 Outer Diameter 2.7 mm In distribution
POP-OB45-14 Outer Diameter 4.5 mm In distribution
POP-LS35-14 Length 14 mm In distribution
POP-OB35-52 Length 52 mm In distribution
POP-CYF250-IC In distribution
POP-M3I In distribution
POP-IMF250-AH In distribution
POP-OB45-32 Length 32 mm In distribution
POP-LS27-22 Length 22 mm In distribution
POP-LS45-32 Length 32 mm In distribution
POP-CB-45 Length 45 mm In distribution
POP-CB-30 Length 30 mm In distribution
POP-OB35-24 Length 24 mm In distribution
POP-CB-60 Length 60 mm In distribution
POP-LS45-12 Length 12 mm In distribution
POP-LS45-24 Length 24 mm In distribution
POP-LS35-32 Outer Diameter 3.5 mm In distribution
POP-OB27-48 Outer Diameter 2.7 mm In distribution
POP-IVR-120 Angle 120 ° In distribution
POP-IB-40 Length 40 mm In distribution
POP-OB45-40 Length 40 mm In distribution
POP-LS27-18 Outer Diameter 2.7 mm In distribution
POP-LS45-36 Outer Diameter 4.5 mm In distribution
POP-AB-50 Length 50 mm In distribution
POP-OB27-12 Length 20 mm In distribution
POP-OB45-48 Outer Diameter 4.5 mm In distribution
POP-OB27-26 Outer Diameter 2.7 mm In distribution
POP-HVR-110 Angle 110 ° In distribution
POP-OB35-22 Outer Diameter 3.5 mm In distribution
POP-M5A In distribution
POP-OB45-60 Outer Diameter 4.5 mm In distribution
POP-LS35-28 Outer Diameter 3.5 mm In distribution
POP-LS35-26 Length 26 mm In distribution
POP-OB35-44 Outer Diameter 3.5 mm In distribution
POP-OB45-16 Outer Diameter 4.5 mm In distribution
POP-LS45-28 Length 28 mm In distribution
POP-CVR-120 Angle 120 ° In distribution
POP-LS35-18 Length 18 mm In distribution
POP-OB35-20 Outer Diameter 3.5 mm In distribution
POP-OB45-12 Length 12 mm In distribution
POP-IMF150 In distribution
POP-OB45-44 Length 44 mm In distribution
POP-AVL-140 Angle 140 ° In distribution
POP-IVR-090 Angle 90 ° In distribution
POP-OB35-32 Length 32 mm In distribution
POP-CVR-090 Angle 90 ° In distribution
POP-OB35-60 Length 60 mm In distribution
POP-AB-65 Length 65 mm In distribution
POP-AVL-120 Angle 120 ° In distribution
POP-IMF250-IC In distribution
POP-AVR-120 Angle 120 ° In distribution
POP-IB-25 Length 25 mm In distribution
POP-AB-45 Length 45 mm In distribution
POP-OB45-24 Outer Diameter 4.5 mm In distribution
POP-OB27-20 Outer Diameter 2.7 mm In distribution
POP-OB35-14 Length 14 mm In distribution
POP-M4C In distribution
POP-CB-50 Length 50 mm In distribution
POP-LS35-40 Outer Diameter 3.5 mm In distribution
POP-OB27-60 Length 60 mm In distribution
POP-OB35-40 Length 40 mm In distribution
POP-M5C-A/H In distribution
POP-LS45-22 Length 22 mm In distribution
POP-AB-60 Length 60 mm In distribution
POP-IB-45 Length 45 mm In distribution
POP-OB27-24 Length 24 mm In distribution
POP-HVL-140 Angle 140 ° In distribution
POP-IVR-110 Angle 110 ° In distribution
POP-AVR-090 Angle 90 ° In distribution
POP-OB35-48 Outer Diameter 3.5 mm In distribution
POP-LS35-16 Length 16 mm In distribution
POP-LS27-32 Outer Diameter 2.7 mm In distribution
POP-AB70 Length 70 mm In distribution
POP-LS45-14 Length 14 mm In distribution
POP-OB27-28 Outer Diameter 2.7 mm In distribution
POP-IVR-100 Angle 100 ° In distribution
POP-OB45-20 Outer Diameter 4.5 mm In distribution
POP-LS27-28 Outer Diameter 2.7 mm In distribution
POP-M4C-I/C In distribution
POP-OB45-22 Outer Diameter 4.5 mm In distribution
POP-CYF250-AH In distribution
POP-OB45-28 Outer Diameter 4.5 mm In distribution
POP-LS35-36 Outer Diameter 3.5 mm In distribution
POP-LS27-14 Length 14 mm In distribution
POP-OB27-36 Length 36 mm In distribution
POP-LS45-40 Length 40 mm In distribution
POP-OB27-14 Length 14 mm In distribution
POP-IVL-120 Angle 120 ° In distribution
POP-IB-30 Length 30 mm In distribution
POP-OB35-36 Length 36 mm In distribution
POP-IVL-130 Angle 130 ° In distribution
POP-LS45-20 Length 20 mm In distribution
POP-OB35-56 Length 56 mm In distribution
POP-LS35-12 Length 12 mm In distribution
POP-LS27-36 Outer Diameter 2.7 mm In distribution
POP-CB-55 Length 55 mm In distribution
POP-HVR-090 Angle 90 ° In distribution
POP-OB35-28 Length 28 mm In distribution
POP-AVL-130 Angle 130 ° In distribution
POP-OB27-32 Outer Diameter 2.7 mm In distribution
POP-OB27-56 Length 56 mm In distribution
POP-IVL-140 Angle 140 ° In distribution
POP-AB-40 Length 40 mm In distribution
POP-CVR-110 Angle 110 ° In distribution
POP-HVL-120 Angle 120 ° In distribution
POP-OB45-26 Outer Diameter 4.5 mm In distribution
POP-LS27-26 Outer Diameter 2.7 mm In distribution
POP-OB45-52 Outer Diameter 4.5 mm In distribution
POP-AB-55 Length 55 mm In distribution
POP-IB-35 Length 35 mm In distribution
POP-CVR-100 Angle 100 ° In distribution
POP-OB27-40 Outer Diameter 2.7 mm In distribution
POP-HVR-120 Angle 120 ° In distribution
POP-AVR-110 Angle 110 ° In distribution
POP-LS35-20 Length 20 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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LCP Synthes Gmbh 355
Orthex External Fixation System Orthopediatrics, Corp 353
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Sterilmed, Inc. 325
CHS Smith & Nephew, Inc. 321
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Stryker Sustainability Solutions 277
Hoffmann Stryker GmbH 239
Orthex Orthopediatrics, Corp 231
Orthex Vilex IN Tennessee, Inc. 221
Omega Stryker GmbH 212
eZ-Fix Orthopediatrics, Corp 207

Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer