Erisma®-LP Evo 15075555
GUDID 03700780651610
LATERAL UNIPLANAR SCREW
CLARIANCE
Spinal bone screw, non-bioabsorbable| Primary Device ID | 03700780651610 |
| NIH Device Record Key | 57400028-c12c-4024-8242-c763586bb02d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Erisma®-LP Evo |
| Version Model Number | 15075555 |
| Catalog Number | 15075555 |
| Company DUNS | 296568400 |
| Company Name | CLARIANCE |
| 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 | true |
| 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 Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 55 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03700780651610 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241863
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
[03700780651610]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-09 |
| Device Publish Date | 2024-09-01 |
On-Brand Devices [Erisma®-LP Evo]
| 03700780652167 | LATERAL UNIPLANAR SCREW |
| 03700780652150 | LATERAL UNIPLANAR SCREW |
| 03700780652143 | LATERAL UNIPLANAR SCREW |
| 03700780652136 | LATERAL UNIPLANAR SCREW |
| 03700780652129 | LATERAL UNIPLANAR SCREW |
| 03700780652112 | LATERAL UNIPLANAR SCREW |
| 03700780652105 | LATERAL UNIPLANAR SCREW |
| 03700780652099 | LATERAL UNIPLANAR SCREW |
| 03700780652082 | LATERAL UNIPLANAR SCREW |
| 03700780652075 | LATERAL UNIPLANAR SCREW |
| 03700780652068 | LATERAL UNIPLANAR SCREW |
| 03700780652051 | LATERAL UNIPLANAR SCREW |
| 03700780652044 | LATERAL UNIPLANAR SCREW |
| 03700780652037 | LATERAL UNIPLANAR SCREW |
| 03700780652020 | LATERAL UNIPLANAR SCREW |
| 03700780652013 | LATERAL UNIPLANAR SCREW |
| 03700780652006 | LATERAL UNIPLANAR SCREW |
| 03700780651993 | LATERAL UNIPLANAR SCREW |
| 03700780651986 | LATERAL UNIPLANAR SCREW |
| 03700780651979 | LATERAL UNIPLANAR SCREW |
| 03700780651962 | LATERAL UNIPLANAR SCREW |
| 03700780651955 | LATERAL UNIPLANAR SCREW |
| 03700780651948 | LATERAL UNIPLANAR SCREW |
| 03700780651931 | LATERAL UNIPLANAR SCREW |
| 03700780651924 | LATERAL UNIPLANAR SCREW |
| 03700780651917 | LATERAL UNIPLANAR SCREW |
| 03700780651900 | LATERAL UNIPLANAR SCREW |
| 03700780651894 | LATERAL UNIPLANAR SCREW |
| 03700780651887 | LATERAL UNIPLANAR SCREW |
| 03700780651870 | LATERAL UNIPLANAR SCREW |
| 03700780651863 | LATERAL UNIPLANAR SCREW |
| 03700780651856 | LATERAL UNIPLANAR SCREW |
| 03700780651849 | LATERAL UNIPLANAR SCREW |
| 03700780651832 | LATERAL UNIPLANAR SCREW |
| 03700780651825 | LATERAL UNIPLANAR SCREW |
| 03700780651818 | LATERAL UNIPLANAR SCREW |
| 03700780651801 | LATERAL UNIPLANAR SCREW |
| 03700780651795 | LATERAL UNIPLANAR SCREW |
| 03700780651788 | LATERAL UNIPLANAR SCREW |
| 03700780651771 | LATERAL UNIPLANAR SCREW |
| 03700780651764 | LATERAL UNIPLANAR SCREW |
| 03700780651757 | LATERAL UNIPLANAR SCREW |
| 03700780651740 | LATERAL UNIPLANAR SCREW |
| 03700780651733 | LATERAL UNIPLANAR SCREW |
| 03700780651726 | LATERAL UNIPLANAR SCREW |
| 03700780651719 | LATERAL UNIPLANAR SCREW |
| 03700780651702 | LATERAL UNIPLANAR SCREW |
| 03700780651696 | LATERAL UNIPLANAR SCREW |
| 03700780651689 | LATERAL UNIPLANAR SCREW |
| 03700780651672 | LATERAL UNIPLANAR SCREW |
Trademark Results [Erisma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ERISMA 79093033 4152212 Live/Registered |
CLARIANCE S.A.S 2011-01-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.