Identity
- Trade Name
- CURE LP FDA UDI
- Generic Name
- Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
- Model / Reference
- S1-900-455-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B167S1900455000 FDA UDI
- 510(k) Number
- K171538 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Intraoperative orthopaedic bone pin/screw, single-use 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraoperative orthopaedic bone pin/screw, single-use
Cure Lp by Meditech Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e8732f4d-9b19-4205-8c2d-97e217c8fdfc 33 fields · synced May 30, 2026