EXPEDIUM 179712130
GUDID 10705034066745
EXPEDIUM SPINE SYSTEM POLYAXIAL SCREW 5.5 x 10 x 30mm
Medos International Sàrl
Spinal bone screw, non-bioabsorbable| Primary Device ID | 10705034066745 |
| NIH Device Record Key | 0904a8e3-9930-4559-a1dc-20a50bffaf7e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXPEDIUM |
| Version Model Number | 179712130 |
| Catalog Number | 179712130 |
| Company DUNS | 482661753 |
| Company Name | Medos International Sàrl |
| 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 | 10705034066745 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101993
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
Moist Heat or Steam Sterilization
[10705034066745]
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]
| 10705034083865 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 65mm |
| 10705034083858 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 60mm |
| 10705034083841 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 55mm |
| 10705034083834 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 50mm |
| 10705034083827 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 45mm |
| 10705034083810 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 40mm |
| 10705034083803 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 35mm |
| 10705034083797 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 30mm |
| 10705034083780 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 25mm |
| 10705034083773 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 7 x 20mm |
| 10705034083698 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 65mm |
| 10705034083681 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 60mm |
| 10705034083674 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 55mm |
| 10705034083667 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 50mm |
| 10705034083650 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 45mm |
| 10705034083643 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 40mm |
| 10705034083636 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 35mm |
| 10705034083629 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 30mm |
| 10705034083612 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 25mm |
| 10705034083605 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 6 x 20mm |
| 10705034083520 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 65mm |
| 10705034083513 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 60mm |
| 10705034083506 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 55mm |
| 10705034083490 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 50mm |
| 10705034083483 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 45mm |
| 10705034083476 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 40mm |
| 10705034083469 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 35mm |
| 10705034083452 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 30mm |
| 10705034083445 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 25mm |
| 10705034083438 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 5 x 20mm |
| 10705034083339 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 55mm |
| 10705034083322 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 50mm |
| 10705034083315 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 45mm |
| 10705034083308 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 40mm |
| 10705034083292 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 35mm |
| 10705034083285 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 30mm |
| 10705034083278 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 25mm |
| 10705034083261 | EXPEDIUM SPINE SYSTEM DI FAVORED ANGLE REDUCTION SCREW 5.5 x 4.35 x 20mm |
| 10705034172330 | EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 6.35 x 8 x 55mm |
| 10705034458489 | EXPEDIUM SPINE SYSTEM CLOSED ILIAC CONNECTOR 5.5 200mm |
| 10705034458472 | EXPEDIUM SPINE SYSTEM CLOSED ILIAC CONNECTOR 5.5 150mm |
| 10705034458465 | EXPEDIUM SPINE SYSTEM CLOSED ILIAC CONNECTOR 5.5 100mm |
| 10705034458441 | EXPEDIUM SPINE SYSTEM CLOSED ILIAC CONNECTOR 5.5 50mm |
| 10705034458434 | EXPEDIUM SPINE SYSTEM CLOSED ILIAC CONNECTOR 5.5 30mm |
| 10705034078281 | EXPEDIUM SPINE SYSTEM COMMERCIALLY PURE Ti ROD 5.5 x 30mm |
| 10705034512525 | EXPEDIUM Advance Set Screw Inserter, Short |
| 10705034507965 | EXPEDIUM Advance Set Screw Inserter, Long |
| 10705034301709 | EXPEDIUM SPINE SYSTEM BOLT DISTRACTOR |
| 10705034219493 | EXPEDIUM ANTERIOR SPINE SYSTEM SELF-RETAINING INSERTER x25 |
| 10705034219486 | EXPEDIUM ANTERIOR SPINE SYSTEM SELF-RETAINING INNIE INSERTER x25 |
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.