CONFIDENCE SPINAL CEMENT SYSTEM 283910000
GUDID 10705034209623
CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc
Medos International Sàrl
Orthopaedic cement preparation/delivery kit| Primary Device ID | 10705034209623 |
| NIH Device Record Key | 36ae6f48-2730-49ab-a4c4-8ec751f71b0f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CONFIDENCE SPINAL CEMENT SYSTEM |
| Version Model Number | 283910000 |
| Catalog Number | 283910000 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Flammable |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034209623 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K060300
FDA Product Code
| NDN | CEMENT, BONE, VERTEBROPLASTY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-03-24 |
| Device Publish Date | 2015-09-24 |
On-Brand Devices [CONFIDENCE SPINAL CEMENT SYSTEM]
| 10705034209548 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, SIDE HOLE 13G x 6 Inches |
| 10705034209531 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, SIDE HOLE 11G x 6 Inches |
| 10705034209524 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, SIDE HOLE 13G x 4 Inches |
| 10705034209517 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, SIDE HOLE 11G x 4 Inches |
| 10705034209500 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 13G x 6 Inches |
| 10705034209494 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G x 6 Inches |
| 10705034209487 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 10G x 5 Inches |
| 10705034209470 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 15G x 4 Inches |
| 10705034209456 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, DIAMOND TIP 11G x 4 Inches |
| 10705034209449 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G x 6 Inches |
| 10705034209432 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 11G x 6 Inches |
| 10705034209425 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 10G x 5 Inches |
| 10705034209418 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 13G x 4 Inches |
| 10705034209401 | CONFIDENCE SPINAL CEMENT SYSTEM INTRODUCER NEEDLE, BEVELED TIP 11G x 4 Inches |
| 20705034462476 | CONFIDENCE SPINAL CEMENT SYSTEM CEMENT RESERVOIR ADAPTER |
| 10705034209630 | CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM |
| 10705034209623 | CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE PLUS KIT SPINAL CEMENT SYSTEM 11cc |
| 10705034209555 | CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM 5cc |
Trademark Results [CONFIDENCE SPINAL CEMENT SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CONFIDENCE SPINAL CEMENT SYSTEM 77416261 3613535 Live/Registered |
DePuy Synthes, Inc. 2008-03-07 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.