Identity
- Trade Name
- HiJAK™ Cervical FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- 8mm LG Lordotic Static Trial, HiJAK™ Cervical FDA UDI
- Model / Reference
- 2019-05-0008 FDA UDI
- Description
- 8mm LG Lordotic Static Trial, HiJAK™ Cervical FDA UDI
Identifiers
- Catalog Number
- 2019-05-0008 FDA UDI
- Primary DI / UDI-DI
- M68120190500080 FDA UDI
- 510(k) Number
- K180675 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 8 Millimeter FDA UDI
Category: Spinal implant trial
HiJAK™ Cervical by Atlas Spine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal implant trial.
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Cleared under the same submission
K180675 also covers:
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
- HiJAK™ Cervical — ATLAS SPINE INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Atlas Spine Inc.
Sources (1)
- FDA UDI f7db9183-88f0-41f5-8b37-71d11dd0d78d 37 fields · synced Jun 6, 2026