SIMMETRY+ SI Joint Fusion System
- Primary DI
- 00810204801262
- Brand
- SIMMETRY+ SI Joint Fusion System
- Company
- TENON MEDICAL, INC.
- Model
- 10-S085105-01
- Catalog number
- 10-S085105-01
- Device description
- SImmetry+ Screw 9.5x105 Sharp Tip
- Published
- 2025-12-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| OUR | Sacroiliac Joint Fixation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OUR | Sacroiliac Joint Fixation | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00810204801262 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00810204801262 | 00810204801262 | 810204801262 | 0810204801262 |
GMDN Terms
| Term | Definition |
|---|
| Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated | An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 117014636
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00810204800005 | SImmetry SI Joint Fusion System | 10-SL08540-01 | 10-SL08540-01 | 2025-12-17 |
| 00810204800012 | SImmetry SI Joint Fusion System | 10-SL08545-00 | 10-SL08545-00 | 2025-12-17 |
| 00810204800029 | SImmetry SI Joint Fusion System | 10-SL08550-01 | 10-SL08550-01 | 2025-12-17 |
| 00810204800036 | SImmetry SI Joint Fusion System | 10-SL08555-01 | 10-SL08555-01 | 2025-12-17 |
| 00810204800043 | SImmetry SI Joint Fusion System | 10-SL08560-01 | 10-SL08560-01 | 2025-12-17 |
| 00810204800050 | SImmetry SI Joint Fusion System | 10-SL08565-01 | 10-SL08565-01 | 2025-12-17 |
| 00810204800067 | SImmetry SI Joint Fusion System | 10-SL08570-01 | 10-SL08570-01 | 2025-12-17 |
| 00810204800074 | SImmetry SI Joint Fusion System | 10-SL08575-01 | 10-SL08575-01 | 2025-12-17 |
| 00810204800081 | SImmetry SI Joint Fusion System | 10-SL08580-01 | | 2025-12-17 |
| 00810204800098 | SImmetry SI Joint Fusion System | 10-SL08585-01 | 10-SL08585-01 | 2025-12-17 |
| 00810204800104 | SImmetry SI Joint Fusion System | 10-SL08590-01 | 10-SL08590-01 | 2025-12-17 |
| 00810204800111 | SImmetry SI Joint Fusion System | 10-SL08595-01 | | 2025-12-17 |
| 00810204800128 | SImmetry SI Joint Fusion System | 10-SL085100-01 | 10-SL085100-01 | 2025-12-17 |
| 00810204800135 | SImmetry SI Joint Fusion System | 10-SL085105-01 | 10-SL085105-01 | 2025-12-17 |
| 00810204800142 | SImmetry SI Joint Fusion System | 10-SL085110-01 | 10-SL085110-01 | 2025-12-17 |
| 00810204800159 | SImmetry SI Joint Fusion System | 10-SL10540-01 | | 2025-12-17 |
| 00810204800166 | SImmetry SI Joint Fusion System | 10-SL10545-01 | 10-SL10545-01 | 2025-12-17 |
| 00810204800173 | SImmetry SI Joint Fusion System | 10-SL10550-01 | | 2025-12-17 |
| 00810204800180 | SImmetry SI Joint Fusion System | 10-SL10555-01 | 10-SL10555-01 | 2025-12-17 |
| 00810204800197 | SImmetry SI Joint Fusion System | 10-SL10560-01 | 10-SL10560-01 | 2025-12-17 |
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