| Primary Device ID | 00810204800036 |
| NIH Device Record Key | 06644681-c3e2-4525-8d14-c2cd46a6e8cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SImmetry SI Joint Fusion System |
| Version Model Number | 10-SL08555-01 |
| Catalog Number | 10-SL08555-01 |
| Company DUNS | 117014636 |
| Company Name | TENON MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00810204800036 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
[00810204800036]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-25 |
| Device Publish Date | 2025-12-17 |
| 00810204802269 | Guide Pin 3.2MM, Trocar |
| 00810204802252 | Guide Pin 3.2MM, Trocar |
| 00810204802245 | Decorticator #3 |
| 00810204802238 | Decorticator #2 |
| 00810204802221 | Decorticator #1 |
| 00810204802214 | Graft Tube, Right Angle |
| 00810204802207 | Implant Driver |
| 00810204802191 | 22mm Sleeve |
| 00810204802184 | 17mm Sleeve |
| 00810204802177 | SImmetry Instrument Tray |
| 00810204802160 | Jacobs Adapter |
| 00810204802153 | Working Cannula |
| 00810204802146 | SV01-20447 |
| 00810204802139 | Impactor |
| 00810204802122 | 9mm Dilator |
| 00810204802115 | 21mm Dilator |
| 00810204802108 | 6mm Drill |
| 00810204802085 | Implant Remover |
| 00810204802078 | Graft Press |
| 00810204802061 | 9mm Drill |
| 00810204802054 | Blunt Pin |
| 00810204802047 | Suction Tube |
| 00810204802030 | Ratcheting Extended Offset T-Handle |
| 00810204802023 | Scraper |
| 00810204802016 | Depth Stop Thumb Screw |
| 00810204800593 | SImmetry Screw 14.5X110 |
| 00810204800586 | SImmetry Screw 14.5X105 |
| 00810204800579 | SImmetry Screw 14.5X100 |
| 00810204800562 | SImmetry Screw 14.5X95 |
| 00810204800555 | SImmetry Screw 14.5X90 |
| 00810204800548 | SImmetry Screw 14.5X85 |
| 00810204800531 | SImmetry Screw 14.5X80 |
| 00810204800524 | 00810204800524 |
| 00810204800517 | SImmetry Screw 14.5X70 |
| 00810204800500 | SImmetry Screw 14.5X65 |
| 00810204800494 | SImmetry Screw 14.5X60 |
| 00810204800487 | SImmetry Screw 14.5X55 |
| 00810204800470 | SImmetry Screw 14.5X50 |
| 00810204800463 | SImmetry Screw 14.5X45 |
| 00810204800456 | SImmetry Screw 14.5X40 |
| 00810204800449 | SImmetry Screw 12.5X110 |
| 00810204800432 | SImmetry Screw 12.5X105 |
| 00810204800425 | SImmetry Screw 12.5X100 |
| 00810204800418 | SImmetry Screw 12.5X95 |
| 00810204800401 | SImmetry Screw 12.5X90 |
| 00810204800395 | SImmetry Screw 12.5X85 |
| 00810204800388 | SImmetry Screw 12.5X80 |
| 00810204800371 | SImmetry Screw 12.5X75 |
| 00810204800364 | SImmetry Screw 12.5X70 |
| 00810204800357 | SImmetry Screw 12.5X65 |