Identity
- Trade Name
- Acumen Thoracolumbar Plate System FDA UDI
- Generic Name
- Bone awl, single-use FDA UDI
- Device Name
- Self-Centering Awl, 3.0 X 15mm FDA UDI
- Model / Reference
- C1155-410 FDA UDI
- Description
- Self-Centering Awl, 3.0 X 15mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C11554100 FDA UDI
- 510(k) Number
- K233360 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Bone awl, 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
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 — 15 Millimeter FDA UDI
Category: Bone awl, single-use
Acumen Thoracolumbar Plate System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone awl, single-use.
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- Gruve — Life Spine, Inc. · Class II
- aprevo® — Carlsmed, Inc. · Class I
- Avitus Pilot Hole Creator, Disposable - 11mm — Avitus Orthopaedics, Inc · Class I
- aprevo® — Carlsmed, Inc. · 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 |
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Manufacturer
- Manufacturer
- Curiteva, LLC
Sources (1)
- FDA UDI a5f48ec9-7e2a-4f7e-a259-b57123d41802 36 fields · synced Jun 8, 2026