Shilla™ Growth Guidance System

Screw 7675430 5.5 Shilla MAS Cann 4.5X30

Registry build 21.09.26
1manufacturer
23catalogue numbers in this listing

Who Else Makes It

Registered in Fujian.

Chinese manufacturers registered for FDA product code PGM
Manufacturer City Province Registered as Device types
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14

Record

Regulatory record for Shilla™ Growth Guidance System
Listed by Medtronic Sofamor Danek, Inc., United States
FDA product code PGM
Device type Growing Rod System
Device class Class 2
Regulation 21 CFR 888.3070
510(k) K140750
Record published 2025-10-04

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Shilla™ Growth Guidance System
Catalogue number Size Status
7673625 In distribution
7673425 In distribution
7673025 In distribution
7675502 In distribution
7673520 In distribution
7675430 In distribution
7673425 In distribution
7673020 In distribution
7675300 In distribution
7675500 In distribution
7675625 In distribution
7675630 In distribution
7676030 In distribution
7675430 In distribution
7675500 In distribution
7674635 In distribution
7675502 In distribution
7675501 In distribution
7675530 In distribution
7675530 In distribution
7675501 In distribution
7676030 In distribution
7670440 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
VerteGlide Spinal Growth Guidance System Orthopediatrics, Corp 204
CD Horizon® Growth Rod Conversion Set Medtronic Sofamor Danek, Inc. 37
SDS Growing Rod Baat Medical Products B.V. 12
Daytona® Small Stature Seaspine Orthopedics Corporation 8
Expedium Depuy Spine, Inc. 6
MSB Shilla Growth Guidance System Medtronic Sofamor Danek, Inc. 5
XIA Stryker GmbH 4

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