Identity
- Trade Name
- CURE LP FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- 9-42460-35 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B167942460350 FDA UDI
- 510(k) Number
- K171538 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Spinal bone screw, non-bioabsorbable
CURE LP is a small, threaded, implantable rod with a screw head and drive designed for internal spinal fixation. It is made of surgical steel or titanium alloy and provides immobilization and stabilization of spinal segments.
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Cleared under the same submission
K171538 also covers:
- CURE ACP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
- CURE LP — MEDITECH SPINE, LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Meditech Spine, Llc
Sources (1)
- FDA UDI 168b13b6-2177-4ced-a0fe-b631746e5920 33 fields · synced Jun 27, 2026