Identity
- Trade Name
- Harrier,SA FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- MEDTORQUE,HDL,AXIAL,TORQ,CCW,18IN-LBS FDA UDI
- Model / Reference
- 2TS4-18-C06 FDA UDI
- Description
- MEDTORQUE,HDL,AXIAL,TORQ,CCW,18IN-LBS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996192569 FDA UDI
- 510(k) Number
- K191367 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Spinal fixation plate, non-bioabsorbable
Harrier, SA by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
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- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K191367 also covers:
- HARRIER SA — Choicespine, LP
- HARRIER SA — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — Choicespine, LP
- Harrier SA — 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 |
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Manufacturer
- Manufacturer
- Choicespine, LP
Sources (1)
- FDA UDI ee6886b2-9914-42b7-9117-88bd8f8730c7 34 fields · synced May 30, 2026