CATAMARAN™ SIJ Fusion System 40295-04
GUDID 00850033676013
Implant, CAT-04, 10mm x 40mm
TENON MEDICAL, INC.
Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile| Primary Device ID | 00850033676013 |
| NIH Device Record Key | de5547b7-cbfd-4d56-865d-1dc0f8708778 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CATAMARAN™ SIJ Fusion System |
| Version Model Number | 40295-04 |
| Catalog Number | 40295-04 |
| 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 | 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033676013 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180818
FDA Product Code
| OUR | Sacroiliac Joint Fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
[00850033676013]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
On-Brand Devices [CATAMARAN™ SIJ Fusion System]
| 00850033676273 | CATAMARAN™ SIJ Fusion System |
| 00850033676266 | Lid, Sterilization Tray, Catamaran |
| 00850033676259 | Sterilization Tray, Catamaran |
| 00850033676242 | Drill Bit 10mmx60mm, Catamaran |
| 00850033676235 | Drill Bit 10mmx40mm, Catamaran |
| 00850033676228 | Flange, Slap Hammer, Catamaran |
| 00850033676211 | Rod, Slap Hammer, Catamaran |
| 00850033676204 | Slap Hammer, Catamaran |
| 00850033676198 | Extraction Screw, 10mm, Catamaran |
| 00850033676181 | Extraction Fork 10mm, Catamaran |
| 00850033676174 | Bone Pusher Rod 10mm, Catamaran |
| 00850033676167 | Bone Pusher Head 10mm, Catamaran |
| 00850033676150 | Funnel Cone 10mm, Catamaran |
| 00850033676143 | Funnel Tube 10mm, Catamaran |
| 00850033676136 | Hex Key 4mm, Catamaran |
| 00850033676129 | Inserter Screw 10mm, Catamaran |
| 00850033676112 | Inserter 10mm, Catamaran |
| 00850033676105 | Temporary Pin 10mm, Catamaran |
| 00850033676099 | Ball Tip Probe, Catamaran |
| 00850033676082 | Drill Bit 10mmx50mm, Catamaran |
| 00850033676075 | Drill Guide 10mm, Catamaran |
| 00850033676068 | Awl, 10mm, Catamaran |
| 00850033676051 | K-Wire, Catamaran |
| 00850033676044 | Graduated Guide Wire, Catamaran |
| 00850033676037 | Handle, Access Sleeve, Catamaran |
| 00850033676020 | Access Sleeve, Catamaran |
| 00850033676013 | Implant, CAT-04, 10mm x 40mm |
| 00850033676006 | Implant, CAT-03, 10mm x 30mm |
| 00850033676303 | Lid, Instrument Tray, Catamaran |
| 00850033676297 | Base, Instrument Tray, Catamaran |
| 00850033676280 | Drill Bit 10mmx70mm, Catamaran |
Trademark Results [CATAMARAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CATAMARAN 98497891 not registered Live/Pending |
BRAEMAR PARTNERSHIP 2024-04-12 |
 CATAMARAN 97711314 not registered Live/Pending |
Evans Hotels, LLC 2022-12-09 |
 CATAMARAN 97482311 not registered Live/Pending |
Tenon Medical, Inc. 2022-06-29 |
 CATAMARAN 88858003 not registered Live/Pending |
Catamaran Bio, Inc. 2020-04-02 |
 CATAMARAN 87028912 5136008 Live/Registered |
luxembourg industries ltd 2016-05-08 |
 CATAMARAN 86680153 4919608 Live/Registered |
Home Brew Mart, Inc. 2015-07-01 |
 CATAMARAN 86637952 4877509 Live/Registered |
Insightful Products, LLC 2015-05-21 |
 CATAMARAN 86633216 4867133 Live/Registered |
Foot Levelers, Inc. 2015-05-18 |
 CATAMARAN 86560488 4844712 Live/Registered |
Blueprint Automation B.V. 2015-03-11 |
 CATAMARAN 85978290 4344276 Dead/Cancelled |
SXC Health Solutions, Inc. 2012-05-15 |
 CATAMARAN 85625926 not registered Dead/Abandoned |
CATAMARAN LLC 2012-05-15 |
 CATAMARAN 85227190 not registered Dead/Abandoned |
NZ Wines, LLC 2011-01-26 |
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