Identity
- Trade Name
- HiJAK™ Cervical FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- Cervical Distractor, HiJAK™ Cervical FDA UDI
- Model / Reference
- 2019-01-0009 FDA UDI
- Description
- Cervical Distractor, HiJAK™ Cervical FDA UDI
Identifiers
- Catalog Number
- 2019-01-0009 FDA UDI
- Primary DI / UDI-DI
- M68120190100090 FDA UDI
- 510(k) Number
- K180675 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Orthopaedic surgical distractor, internal 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: Orthopaedic surgical distractor, internal
HiJAK™ Cervical by Atlas Spine Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 499d5a87-c053-4623-bc3f-e7efc8eb07c4 36 fields · synced Jun 1, 2026