Identity
- Trade Name
- HARRIER-SA Lumbar Interbody System FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- HARRIER-SA,Drill,U-Joint Variable Angle FDA UDI
- Model / Reference
- Y070-0014 FDA UDI
- Description
- HARRIER-SA,Drill,U-Joint Variable Angle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840996186223 FDA UDI
- 510(k) Number
- K180519 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable 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: Fluted surgical drill bit, reusable
HARRIER-SA Lumbar Interbody System by Choicespine, LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, reusable.
- RingLoc® + — Biomet Orthopedics, Inc. · Class I
- DLC Cortical Bone Drill 5.7mmD Implant — IMPLANT DIRECT SYBRON MANUFACTURING LLC · Class II
- MatrixMANDIBLE — Synthes · Class II
- Brasseler — SUNCOAST DENTAL, INC. · Class I
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- ROTACYJNE NARZĘDZIA CHIRURGICZNE — ChM spółka z ograniczoną odpowiedzialnością · Class IIa
- Revision Knee System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class I
- Straight Twist Drill — DENTIS CO. , LTD · Class I
Cleared under the same submission
K180519 also covers:
- HARRIER-SA — Choicespine, LP
- HARRIER-SA LUMBAR INTERBODY SYSTEM — Choicespine, LP
- HARRIER-SA LUMBAR INTERBODY SYSTEM — Choicespine, LP
- HARRIER-SA LUMBAR INTERBODY SYSTEM — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — Choicespine, LP
- HARRIER-SA Lumbar Interbody System — 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 a50506d3-c5d7-4a85-a64b-8b42439e725b 34 fields · synced Jun 6, 2026