Identity
- Trade Name
- Octane Straight FDA UDI
- Generic Name
- Intervertebral-body internal spinal fixation system FDA UDI
- Device Name
- Octane Straight Trail 24mmX10mmX12mm FDA UDI
- Model / Reference
- 05-049-20-0012 FDA UDI
- Description
- Octane Straight Trail 24mmX10mmX12mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996177344 FDA UDI
- 510(k) Number
- K150152 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Intervertebral-body internal spinal fixation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intervertebral-body internal spinal fixation system
Octane Straight by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intervertebral-body internal spinal fixation system.
- Tyber Medical — Tyber Medical · Class II
- BP® — ZIMMER SPINE, INC. · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
- Tyber Medical — Tyber Medical · Class II
- Tyber Medical — Tyber Medical · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
- Fortitude® — ZIMMER SPINE, INC. · Class II
- Maxima™ ACP System — CG MedTech Co., Ltd. · Class II
Cleared under the same submission
K150152 also covers:
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
- Octane Straight — Choicespine, LP
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI 6c5bc5f4-487c-4c7e-bf60-e4f9ef673553 35 fields · synced May 30, 2026