Identity
- Trade Name
- SmartLOX Cervical Plate System FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- 11mm Drill Bit Spade Tip FDA UDI
- Model / Reference
- 13340-0011 FDA UDI
- Description
- 11mm Drill Bit Spade Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7391334000110 FDA UDI
- 510(k) Number
- K141332 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
- Not 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
SmartLOX Cervical Plate System by Captiva Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K141332 also covers:
- 1-Level Cervical Plates, 20 mm — Captiva Spine
- 1-Level Cervical Plates, 22 mm — Captiva Spine
- 1-Level Cervical Plates, 24 mm — Captiva Spine
- 1-Level Cervical Plates, 26 mm — Captiva Spine
- 1-Level Cervical Plates, 28 mm — Captiva Spine
- 1-Level Cervical Plates, 30 mm — Captiva Spine
- 1-Level Cervical Plates, 32 mm — Captiva Spine
- 1-Level Cervical Plates, 34 mm — Captiva Spine
- 2-Level Cervical Plates, 36 mm — Captiva Spine
- 2-Level Cervical Plates, 38 mm — Captiva Spine
- 2-Level Cervical Plates, 40 mm — Captiva Spine
- 2-Level Cervical Plates, 42 mm — Captiva Spine
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
- Captiva Spine
Sources (1)
- FDA UDI 0baffbb6-a4c9-4396-8543-cf7456777e4b 36 fields · synced May 29, 2026