ANAX™ 5.5 SPINAL SYSTEM
GUDID 08800015992671
Innosys Co., Ltd.
Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 08800015992671 |
| NIH Device Record Key | f980598a-72c5-4133-a2e9-1f0a5029facf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANAX™ 5.5 SPINAL SYSTEM |
| Version Model Number | SFCA6060 |
| Company DUNS | 688811082 |
| Company Name | Innosys Co., Ltd. |
| 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 | true |
| 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 | 08800015992671 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132101
FDA Product Code
| MNH | Orthosis, spondylolisthesis spinal fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
[08800015992671]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2018-03-16 |
On-Brand Devices [ANAX™ 5.5 SPINAL SYSTEM]
Trademark Results [ANAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANAX 97056657 not registered Live/Pending |
Anaxdent North America LLC 2021-10-01 |
 ANAX 88571862 not registered Live/Pending |
Corbett & Brown Inc. 2019-08-08 |
 ANAX 87276522 5237188 Live/Registered |
Microtech Knives, Inc. 2016-12-21 |
 ANAX 86459418 4772772 Live/Registered |
ANAX Business Technologies, LLC 2014-11-19 |
 ANAX 79024628 3275432 Dead/Cancelled |
DOMAINE GEROVASSILIOU S.A. 2006-05-22 |
 ANAX 77205255 not registered Dead/Abandoned |
Archon Capital Management LLC 2007-06-13 |
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