Identity
- Trade Name
- KIT: VCF Treatment, LEFT, FRACTURE FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Model / Reference
- KIVA2200E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815212024450 FDA UDI
- 510(k) Number
- K141141 FDA UDI
- FDA Product Code
- NDN FDA UDILOD FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic cement, non-antimicrobial
KIT: VCF Treatment, LEFT, FRACTURE 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
K141141 also covers:
- KIT: VCF Treatment, RIGHT, FRACTURE — IZI MEDICAL PRODUCTS LLC
- KIT:VCF TREATMENT, LEFT, FRACTURE — IZI MEDICAL PRODUCTS LLC
- KIT:VCF TREATMENT, RIGHT, FRACTURE — IZI MEDICAL PRODUCTS LLC
- KIVA INTRODUCER SET — IZI MEDICAL PRODUCTS LLC
- KIVA ULTRAFLEX CEMENT NEEDLE KIT — IZI MEDICAL PRODUCTS LLC
- PILOT:GEN A, LEFT — IZI MEDICAL PRODUCTS LLC
- PILOT:GEN A, RIGHT — 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 e023a487-f9de-4767-85f7-b3bdd7d74f82 33 fields · synced May 30, 2026