SambaScrew
GUDID 18257200119219
9mm x 45 mm SambaScrew
ORTHOFIX INC.
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile| Primary Device ID | 18257200119219 |
| NIH Device Record Key | 790e4697-9f55-4e09-a690-828c680bc6e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SambaScrew |
| Version Model Number | 11-1109-5 |
| Company DUNS | 927083808 |
| Company Name | ORTHOFIX INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
Device Dimensions
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
| Width | 9 Millimeter |
| Length | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18257200119219 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121148
FDA Product Code
| HWC | Screw, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
[18257200119219]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-06 |
On-Brand Devices [SambaScrew]
| 18257200119226 | 9mm x 50 mm SambaScrew |
| 18257200119219 | 9mm x 45 mm SambaScrew |
| 18257200119202 | 9mm x 40 mm SambaScrew |
| 18257200119196 | 9mm x 35mm SambaScrew |
| 18257200119189 | 9mm x 30mm SambaScrew |
| 18257200119172 | 9mm x 25mm SambaScrew |
Trademark Results [SambaScrew]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAMBASCREW 85844239 4530640 Live/Registered |
Asfora, Wilson T. 2013-02-07 |
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