Synex 04807233
GUDID H981048072330
SYNEX(TM) W/LRG ENDPLATE/OPEN 10 DEG/33MM-48MM HEIGHT (TI)
SYNTHES (U.S.A.) LP
Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis| Primary Device ID | H981048072330 |
| NIH Device Record Key | af2ce6a1-bf5b-4e46-8aab-bfb1da7a90a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Synex |
| Version Model Number | 04.807.233 |
| Catalog Number | 04807233 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | true |
| 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
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034753089 [Primary] |
| HIBCC | H981048072330 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003836
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
[H981048072330]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-13 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [Synex]
| H9814953270 | SYNEX(TM) WITH LARGE ENDPLATE -6 DEG/45MM-73MM HEIGHT |
| H9814953250 | SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/36MM-56MM HEIGHT |
| H9814953230 | SYNEX(TM) WITH LARGE ENDPLATE 20 DEG/37MM-55MM HEIGHT |
| H9814953210 | SYNEX(TM) WITH LARGE ENDPLATE 10 DEG/33MM-48MM HEIGHT |
| H9814953200 | SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/20MM-25MM HEIGHT |
| H9814953190 | SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/31MM-46MM HEIGHT |
| H9814953180 | SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/28MM-40MM HEIGHT |
| H9814953170 | SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/26MM-36MM HEIGHT |
| H9814953160 | SYNEX(TM) WITH LARGE ENDPLATE 0 DEG/23MM-31MM HEIGHT |
| H9814953150 | SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/23MM-31MM HEIGHT |
| H9816900520 | SYNEX(TM) SYSTEM INSTRUMENT AND IMPLANT SET GRAPHIC CASE |
| H981608070100 | MODULE CASE FOR SYNEX(TM) OPEN IMPLANTS |
| H981048072450 | SYNEX(TM) W/LRG ENDPLATE/OPEN -6 DEG/45MM-73MM HEIGHT (TI) |
| H981048072370 | SYNEX(TM) W/LRG ENDPLATE/OPEN 20 DEG/37MM-55MM HEIGHT (TI) |
| H981048072330 | SYNEX(TM) W/LRG ENDPLATE/OPEN 10 DEG/33MM-48MM HEIGHT (TI) |
| H981048072310 | SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/31MM-46MM HEIGHT (TI) |
| H981048072260 | SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/26MM-36MM HEIGHT (TI) |
| H981048072230 | SYNEX(TM) W/LRG ENDPLATE/OPEN 0 DEG/23MM-31MM HEIGHT (TI) |
| H981048071360 | SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/36MM-56MM HEIGHT (TI) |
| H981048071280 | SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/28MM-40MM HEIGHT (TI) |
| H981048071230 | SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/23MM-31MM HEIGHT (TI) |
| H981048071200 | SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/20MM-25MM HEIGHT (TI) |
Trademark Results [Synex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNEX 87941580 5915805 Live/Registered |
Jeongsan International Co., Ltd. 2018-05-30 |
 SYNEX 87941517 5915804 Live/Registered |
Jeongsan International Co., Ltd. 2018-05-30 |
 SYNEX 85047372 4132452 Dead/Cancelled |
Fulton Management Services, Inc. 2010-05-25 |
 SYNEX 79048151 not registered Dead/Abandoned |
NASH CONSUMER ELECTRONICS PTE LTD 2007-04-05 |
 SYNEX 78682127 not registered Dead/Abandoned |
Erika Desnoes 2005-07-30 |
 SYNEX 78092160 not registered Dead/Abandoned |
Synex Comercio E Servicos LTDA. 2001-11-07 |
 SYNEX 76380783 2781269 Live/Registered |
DEPUY SYNTHES, INC. 2002-03-05 |
 SYNEX 76093454 2473609 Dead/Cancelled |
GRETAG IMAGING AG 2000-07-12 |
 SYNEX 73414935 1269590 Dead/Cancelled |
Paramount Ventures Inc. 1983-02-25 |
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