Identity
- Trade Name
- SmartLOX Cervical Plate System FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Temporary Fixation Pin FDA UDI
- Model / Reference
- CP40001 FDA UDI
- Description
- Temporary Fixation Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- M739CP400010 FDA UDI
- 510(k) Number
- K141332 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, 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: Orthopaedic prosthesis implantation positioning instrument, reusable
SmartLOX Cervical Plate System by Captiva Spine — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.
- DJO SURGICAL — DJO, LLC · Class I
- ALEUTIAN Interbody Systems — K2M, INC. · Class I
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class I
- A/P Sizer, Klassic ONE — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- ARCADIUS XP C — AESCULAP, INC. · Class I
- LUCENT — SPINAL ELEMENTS, INC. · Class I
- U-KneeTec — CORIN LTD · Class II
- NCB® — Zimmer, Inc. · Class II
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 69c52c27-eb97-4689-9a63-87c0d40f6e59 35 fields · synced Jun 8, 2026