Identity
- Trade Name
- 13G BONE FILLER DEVICE SINGLE FDA UDI
- Generic Name
- Bone access cannula FDA UDI
- Model / Reference
- VA11BF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212025587 FDA UDI
- 510(k) Number
- K170008 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Bone access cannula FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
No
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: Bone access cannula
13g Bone Filler Device Single by Izi Medical Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170008 also covers:
- Arcadia Curved Delivery Cannula — IZI MEDICAL PRODUCTS LLC
- CVAK-100 — IZI MEDICAL PRODUCTS LLC
- Kyphoplasty Bone Drill — IZI MEDICAL PRODUCTS LLC
- Kyphoplasty Bone Drill 11G — IZI MEDICAL PRODUCTS LLC
- Kyphoplasty Bone Filler — IZI MEDICAL PRODUCTS LLC
- Kyphoplasty Coaxial Cement Injector — IZI MEDICAL PRODUCTS LLC
- Kyphoplasty Curette — IZI MEDICAL PRODUCTS LLC
- MiniMix CMM1 Pouched Assembly — IZI MEDICAL PRODUCTS LLC
- OS 13G BONE FILLER KIT-HV — IZI MEDICAL PRODUCTS LLC
- Osteo-Site 13G Bone Filler Injection Kit X6 — IZI MEDICAL PRODUCTS LLC
- Osteo-Site Guide Pin — IZI MEDICAL PRODUCTS LLC
- Osteo-Site Mixing and Injection System — IZI MEDICAL PRODUCTS 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
- Izi Medical Products Llc
Sources (1)
- FDA UDI 57157175-f832-431b-bab9-17cfdc57cc07 33 fields · synced May 30, 2026