Identity
- Trade Name
- SI-LUTION Sacroiliac Joint Fusion System FDA UDI
- Generic Name
- Spinal guidewire FDA UDI
- Device Name
- 12mm Fixed Pin Guide FDA UDI
- Model / Reference
- C615-400 FDA UDI
- Description
- 12mm Fixed Pin Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- B648C6154000 FDA UDI
- 510(k) Number
- K191810 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDI
- GMDN Term
- Spinal guidewire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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
- Width — 12 Millimeter FDA UDI
Category: Spinal guidewire
SI-LUTION Sacroiliac Joint Fusion System by Curiteva, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal guidewire.
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- RAVINE® Lateral Access System — K2M, INC. · Class I
- NILE™ Spinal System — K2M, INC. · Class II
- MEGA PLUS MIS SPINE SYSTEM — BK MEDITECH CO., LTD. · Class I
- DeGen Standard Instrumentation — Degen Medical · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
Cleared under the same submission
K191810 also covers:
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw System — Curiteva, LLC
- Prodigy Pedicle Screw 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 ec800937-3056-45dd-9781-7d905184a206 36 fields · synced May 31, 2026