HiJAK™ Cervical 2019-03-0007
GUDID M68120190300070
7mm LG Hyperlordotic Static Trial, HiJAK™ Cervical
ATLAS SPINE, INC.
Spinal implant trial| Primary Device ID | M68120190300070 |
| NIH Device Record Key | 0bea56ca-eda9-471d-a591-4086fb7e37c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiJAK™ Cervical |
| Version Model Number | HiJAK™ Cervical |
| Catalog Number | 2019-03-0007 |
| Company DUNS | 140801007 |
| Company Name | ATLAS SPINE, 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 | 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 |
Device Dimensions
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
| Height | 7 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M68120190300070 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180675
FDA Product Code
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
[M68120190300070]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-08 |
| Device Publish Date | 2019-09-30 |
On-Brand Devices [HiJAK™ Cervical]
| M68120190900140 | 14mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900130 | 13mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900120 | 12mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900110 | 11mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900100 | 10mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900090 | 9mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900080 | 8mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190900070 | 7mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800140 | 14mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800130 | 13mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800120 | 12mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800110 | 11mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800100 | 10mm LG Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800090 | 9mm SM Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800080 | 8mm SM Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190800070 | 7mm SM Lordotic Expanding Trial, HiJAK™ Cervical |
| M68120190700140 | 14mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700130 | 13mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700120 | 12mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700110 | 11mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700100 | 10mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700090 | 9mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190700080 | 8mm LG HL Expanding Trial, HiJAK™ Cervical |
| M68120190600140 | 14mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600130 | 13mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600120 | 12mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600110 | 11mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600100 | 10mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600090 | 9mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190600080 | 8mm SM HL Expanding Trial, HiJAK™ Cervical |
| M68120190500140 | 14mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500130 | 13mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500120 | 12mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500110 | 11mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500100 | 10mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500090 | 9mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500080 | 8mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190500070 | 7mm LG Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400140 | 14mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400130 | 13mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400120 | 12mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400110 | 11mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400100 | 10mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400090 | 9mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400080 | 8mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190400070 | 7mm SM Lordotic Static Trial, HiJAK™ Cervical |
| M68120190300140 | 14mm LG Hyperlordotic Static Trial, HiJAK™ Cervical |
| M68120190300130 | 13mm LG Hyperlordotic Static Trial, HiJAK™ Cervical |
| M68120190300120 | 12mm LG Hyperlordotic Static Trial, HiJAK™ Cervical |
| M68120190300110 | 11mm LG Hyperlordotic Static Trial, HiJAK™ Cervical |
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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