SHILLA™ Growth Guidance System
GUDID 00613994799852
TRAY 7679016 SHLA 4.5 MAS 2 CS 2
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray, reusable| Primary Device ID | 00613994799852 |
| NIH Device Record Key | cc0da39d-14a2-49f3-a91c-32e4423a4fe8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHILLA™ Growth Guidance System |
| Version Model Number | 7679016 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994799852 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190840
FDA Product Code
| FSM | TRAY, SURGICAL, INSTRUMENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
[00613994799852]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-08 |
| Device Publish Date | 2021-02-28 |
On-Brand Devices [SHILLA™ Growth Guidance System]
| 00643169009943 | TRAY 7679029 4.5 MAS |
| 00643169009929 | TRAY 7679027 4.5 FAS |
| 00613994801333 | LID 7679021 SHILLA 4.5 SCRW CADDY CS2 |
| 00613994800008 | TRAY 7679001 SHLA 4.5 INSTR 1 CS 3 |
| 00613994799999 | TRAY 7679002 SHLA 4.5 INSTR 2 CS 3 |
| 00613994799975 | TRAY 7679004 SHLA 4.5 INSTR 1 CS 4 |
| 00613994799968 | TRAY 7679005 SHLA 4.5 INSTR 2 CS 4 |
| 00613994799944 | TRAY 7679007 SHLA 4.5 INSTR 1 CS 5 |
| 00613994799937 | TRAY 7679008 SHLA 4.5 INSTR 2 CS 5 |
| 00613994799920 | TRAY 7679009 SHLA 4.5 INSTR 3 CS 5 |
| 00613994799906 | TRAY 7679011 SHLA 4.5 XLINK INST |
| 00613994799876 | TRAY 7679014 SHLA 4.5 FAS 1CS 1 |
| 00613994799852 | TRAY 7679016 SHLA 4.5 MAS 2 CS 2 |
| 00613994799845 | TRAY 7679017 SHLA 4.5 MAS 1 CS 2 |
| 00613994799838 | CADDY 7679018 SHILLA 4.5 XLINK CDY CS 2 |
| 00613994799821 | LID 7679019 SHLA 4.5 XLINK CDY CS 2 |
| 00613994799814 | CADDY 7679020 SHLA 4.5 ST SCRW CS 2 |
| 00613994798367 | TRAY 7679051 5.5 FAS 1 |
| 00613994798343 | TRAY 7679053 5.5 MAS 2 |
| 00613994798336 | TRAY 7679054 5.5 MAS 1 |
| 00613994798329 | CADDY 7679055 1 SHILLA 5.5 CROSSLINK |
| 00613994798299 | CADDY LID 7679058 5.5 SET SCREW |
| 00613994798275 | TRAY 7679060 5.5 INST 1 |
| 00613994798268 | TRAY 7679061 5.5 INST 2 |
| 00613994798244 | TRAY 7679063 5.5 INST 1 |
| 00613994798237 | TRAY 7679064 5.5 INST 2 |
| 00613994798213 | TRAY 7679066 5.5 INST 1 |
| 00613994798206 | TRAY 7679067 5.5 INST 2 |
| 00613994798190 | TRAY 7679068 5.5 INST 3 |
| 00613994798176 | TRAY 7679070 5.5 XLINK INST 1 |
| 00613994798312 | LID 7679056 5.5 XLINK CDY |
| 00613994798305 | CADDY 7679057 5.5 SET SCREW |
| 00613994803160 | SCREWDRIVER 7674444 4.5 CANNULATED MAS |
| 00763000875220 | SET SCREW 7675501 5.5 SHILLA STANDARD |
| 00763000874810 | SCREW 7675630 5.5 SHILLA MAS CANN 6.5X30 |
| 00763000873653 | ROD 7675300 5.5 SHILLA SS ROD 300 MM |
| 00763000874520 | SCREW 7673520 4.5 SHILLA FAS 5.5X20 |
| 00763000875282 | SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30 |
Trademark Results [SHILLA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHILLA 86036343 4720930 Live/Registered |
Warsaw Orthopedic, Inc. 2013-08-13 |
 SHILLA 85382974 4121295 Dead/Cancelled |
INTERTEX & CO PTY LTD 2011-07-27 |
 SHILLA 77968663 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2010-03-25 |
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