Identity
- Trade Name
- HiJAK™ Cervical FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Short Driver, SM, HiJAK™ Cervical FDA UDI
- Model / Reference
- 2019-01-0015 FDA UDI
- Description
- Short Driver, SM, HiJAK™ Cervical FDA UDI
Identifiers
- Catalog Number
- 2019-01-0015 FDA UDI
- Primary DI / UDI-DI
- M68120190100150 FDA UDI
- 510(k) Number
- K180675 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Surgical screwdriver, reusable 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
Category: Surgical screwdriver, reusable
HiJAK™ Cervical by Atlas Spine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
- MEGA PLUS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- Inclusive — PRISMATIK DENTALCRAFT, INC. · Class I
- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
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 c4ac559f-1078-49b1-ae58-b9b977b3a336 36 fields · synced May 30, 2026