EXPEDIUM 186188630
GUDID 10705034110165
EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 4.5 x 6.0 x 30mm
DEPUY SPINE, LLC
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10705034110165 |
| NIH Device Record Key | cbdd6ca5-5b6b-49ee-a3a3-20fab10b8d99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXPEDIUM |
| Version Model Number | 186188630 |
| Catalog Number | 186188630 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034110165 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K073364
FDA Product Code
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
[10705034110165]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-07-23 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [EXPEDIUM]
| 10705034144986 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 45mm |
| 10705034144979 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 40mm |
| 10705034144962 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 35mm |
| 10705034144955 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 30mm |
| 10705034144825 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 50mm |
| 10705034144818 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 45mm |
| 10705034144801 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 40mm |
| 10705034144795 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 35mm |
| 10705034144788 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 30mm |
| 10705034144771 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 25mm |
| 10705034144641 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 45mm |
| 10705034144634 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 40mm |
| 10705034144627 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 35mm |
| 10705034144610 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 30mm |
| 10705034144603 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 25mm |
| 10705034144597 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 20mm |
| 10705034200880 | EXPEDIUM SPINE SYSTEM TAB KEY FOR EXTENDED TAB SCREWS 6.35 |
| 10705034303123 | EXPEDIUM SPINE SYSTEM OUTER NUT INSERTER 4.5 |
| 10705034224572 | EXPEDIUM SPINE SYSTEM CROSS-CONNECTOR INSERTER |
| 10705034211541 | EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR DISTRACTOR |
| 10705034211527 | EXPEDIUM SPINE SYSTEM IN-LINE APPROXIMATOR INSERTER |
| 10705034211466 | EXPEDIUM SPINE SYSTEM DISTRACTOR |
| 10705034211305 | EXPEDIUM SPINE SYSTEM EXTENDED TAB REMOVER |
| 10705034211183 | EXPEDIUM SPINE SYSTEM NUT INSERTER, CASTLE DRIVE |
| 10705034211169 | EXPEDIUM SPINE SYSTEM INTERMEDIATE TIGHTENER x20 |
| 10705034211121 | EXPEDIUM SPINE SYSTEM FINAL TIGHTENER x20 |
| 10705034211091 | EXPEDIUM SPINE SYSTEM SINGLE INNIE INSERTER |
| 10705034203270 | EXPEDIUM SPINE SYSTEM DEROTATION FLEX CLIP INSERT 5.5 |
| 10705034201184 | EXPEDIUM SPINE SYSTEM INSERTER |
| 10705034201061 | EXPEDIUM SPINE SYSTEM LATERAL REDUCTION INSERTER, 6.35 X25 370mm |
| 10705034201023 | EXPEDIUM SPINE SYSTEM VERTEBRAL-BODY ROTATION TUBE FOR CLIP-ON DEVICE 6.35 |
| 10705034201009 | EXPEDIUM SPINE SYSTEM SI SET SCREW INSERTER FOR CLIP-ON REDUCTION SLEEVE 6.35 |
| 10705034200903 | EXPEDIUM SPINE SYSTEM REDUCTION TAB REMOVER 6.35 |
| 10705034200897 | EXPEDIUM SPINE SYSTEM TAB RING FOR EXTENDED TAB SCREWS 6.35 |
| 10705034200750 | EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION 6.35 |
| 10705034200705 | EXPEDIUM SPINE SYSTEM INSERTER x25 |
| 10705034199283 | EXPEDIUM SPINE SYSTEM DUAL INNER INSERTER |
| 10705034199061 | EXPEDIUM SPINE SYSTEM LATERAL REDUCTION INSERTER, 5.5 X25 370mm |
| 10705034199016 | EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5mm |
| 10705034198477 | EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION |
| 10705034198408 | EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5 |
| 10705034199412 | EXPEDIUM SPINE SYSTEM DRIVER SLEEVE EXTENDED DI 5.5 |
| 10705034211282 | EXPEDIUM SPINE SYSTEM EXTENDED TAB KEY |
| 10705034152820 | EXPEDIUM SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5 x 4.75mm |
| 10705034116815 | EXPEDIUM SPINE SYSTEM SIDE-BY-SIDE EXTENDED 4 SCREW CONNECTOR 4.5 x 5.0mm |
| 10705034116716 | EXPEDIUM SPINE SYSTEM SIDE-BY-SIDE EXTENDED 2 SCREW CONNECTOR 4.5 x 4.75mm |
| 10705034153414 | EXPEDIUM SPINE SYSTEM SINGLE INLINE RODDED CONNECTOR 5.5 x 5.5-6.35 x 200mm |
| 10705034152868 | EXPEDIUM SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5 x 6.35mm |
| 10705034116587 | EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 80mm |
| 10705034116570 | EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 60mm |
Trademark Results [EXPEDIUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXPEDIUM 78421902 3072007 Live/Registered |
DePuy Synthes, Inc. 2004-05-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.