HiJAK™ Stand Alone 1123-01-0008
GUDID M68111230100080
8mm SM FP Lordotic Implant, HiJAK™ Stand Alone
ATLAS SPINE, INC.
Polymeric spinal interbody fusion cage| Primary Device ID | M68111230100080 |
| NIH Device Record Key | f13f1a02-b1e1-4f01-96fc-01d271f800d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiJAK™ Stand Alone |
| Version Model Number | 1123-01-0008 |
| Catalog Number | 1123-01-0008 |
| Company DUNS | 140801007 |
| Company Name | ATLAS SPINE, 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 | true |
| 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 |
Customer Support Contacts
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com | |
| Phone | (561) 741-1108 |
| sales@atlasspine.com |
Device Dimensions
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
| Height | 8 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68111230100080 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180675
FDA Product Code
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
[M68111230100080]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-01 |
| Device Publish Date | 2020-09-23 |
On-Brand Devices [HiJAK™ Stand Alone]
| M68111230400140 | 14mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400130 | 13mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400120 | 12mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400110 | 11mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400100 | 10mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400090 | 9mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230400080 | 8mm LG FP HL Implant, HiJAK™ Stand Alone |
| M68111230300140 | 14mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300130 | 13mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300120 | 12mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300110 | 11mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300100 | 10mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300090 | 9mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230300080 | 8mm SM FP HL Implant, HiJAK™ Stand Alone |
| M68111230200140 | 14mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200130 | 13mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200120 | 12mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200110 | 11mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200100 | 10mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200090 | 9mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200080 | 8mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230200070 | 7mm LG FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100140 | 14mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100130 | 13mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100120 | 12mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100110 | 11mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100100 | 10mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100090 | 9mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100080 | 8mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
| M68111230100070 | 7mm SM FP Lordotic Implant, HiJAK™ Stand Alone |
Trademark Results [HiJAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIJAK 88192134 5780714 Live/Registered |
Atlas Spine, Inc. 2018-11-13 |
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