| Primary Device ID | B742403250 |
| NIH Device Record Key | ad87184b-45c4-4d2a-b0ea-51b2598c0faf |
| Commercial Distribution Discontinuation | 2021-12-03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) |
| Version Model Number | 40325 |
| Catalog Number | 40325 |
| Company DUNS | 117014636 |
| Company Name | TENON MEDICAL, INC. |
| 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 | false |
| 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 |
|---|---|
| HIBCC | B742403250 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
[B742403250]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-11-24 |
| Device Publish Date | 2020-06-12 |
| B74240308160 | 7.5mm Insertion Handle |
| B74240308150 | 7.5mm Drill Spacer 5mm |
| B74240308140 | 7.5mm Drill Spacer 10mm |
| B74240308130 | 7.5mm Drill Spacer 20mm |
| B74240308120 | 7.5mm Drill Stop |
| B74240308110 | 7.5mm Extraction Screw |
| B74240308100 | 7.5mm Extraction Fork |
| B74240308090 | 7.5mm Bone Tamp Rod |
| B74240308070 | 7.5mm Location Pin |
| B74240308060 | 7.5mm Drill Guide |
| B74240308050 | 7.5mm Center Punch |
| B74240308040 | K-Wire |
| B74240308030 | Graduated Guide Wire |
| B74240308020 | Access Sleeve Handle |
| B74240308010 | Access Sleeve |
| B74240295040 | 10X40mm SIJ Implant |
| B74240295030 | 10X30mm SIJ Implant |
| B74240295020 | 7.5X40mm SIJ Implant |
| B74240295010 | 7.5X30mm SIJ Implant |
| B742403250 | Implant Sterilizing Tray (Trimmed) |
| B742403240 | Access Sterilizing Tray (Trimmed) |
| B742403230 | Extraction Sterilizing Tray (Trimmed) |
| B742403220 | Drill Sterilizing Tray (Trimmed) |
| B74240308440 | Drill Probe |
| B74240308410 | 7.5mm Drill |
| B74240308400 | 4mm Hex Key |
| B74240308390 | 10mm Bone Tamp Head |
| B74240308380 | 7.5mm Bone Tamp Head |
| B74240308370 | 10mm Funnel Flange |
| B74240308360 | 7.5mm Funnel Flange |
| B74240308350 | 10mm Funnel |
| B74240308340 | 7.5mm Funnel |
| B74240308330 | Handle Flange |
| B74240308320 | Slap Hammer Rod |
| B74240308310 | Slap Hammer Handle |
| B74240308300 | 10mm Insertion Screw |
| B74240308290 | 10mm Insertion Handle |
| B74240308280 | 10mm Drill Spacer 5mm |
| B74240308270 | 10mm Drill Spacer 10mm |
| B74240308260 | 10mm Drill Spacer 20mm |
| B74240308250 | 10mm Drill Stop |
| B74240308240 | 10mm Extraction Screw |
| B74240308230 | 10mm Extraction Fork |
| B74240308220 | 10mm Bone Tamp Rod |
| B74240308210 | 10mm Drill |
| B74240308200 | 10mm Location Pin |
| B74240308190 | 10mm Drill Guide |
| B74240308180 | 10mm Center Punch |
| B74240308170 | 7.5mm Insertion Screw |