Identity
- Trade Name
- Acumen Thoracolumbar Plate System FDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Drill, 3.0 x 20mm FDA UDI
- Model / Reference
- C1155-500-20 FDA UDI
- Description
- Drill, 3.0 x 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C1155500200 FDA UDI
- 510(k) Number
- K233360 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Cannulated surgical drill bit, reusable 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Millimeter FDA UDILength — 20 Millimeter FDA UDI
Category: Cannulated surgical drill bit, reusable
Acumen Thoracolumbar Plate System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cannulated surgical drill bit, reusable.
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- 4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
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- EBA2 — Citieffe · Class II
- Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
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- BIXCUT — Stryker Corp. · Class I
- FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I
Cleared under the same submission
K233360 also covers:
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, LLC
- Acumen Thoracolumbar Plate System — Curiteva, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Curiteva, LLC
Sources (1)
- FDA UDI 11f11966-3685-4311-807f-051590e5cb04 36 fields · synced May 30, 2026