Identity
- Trade Name
- iVAS FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- Inflatable Vertebral Augmentation System FDA UDI
- Model / Reference
- 0705310000 FDA UDI
- Description
- Inflatable Vertebral Augmentation System FDA UDI
Identifiers
- Catalog Number
- 0705-310-000 FDA UDI
- Primary DI / UDI-DI
- 07613252505983 FDA UDI
- FDA Product Code
- NDN FDA UDI
- GMDN Term
- Balloon kyphoplasty kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3027 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 11.0 Gauge FDA UDILength — 10.0 Millimeter FDA UDI
iVAS by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Stryker Corp.
Sources (1)
- FDA UDI 994fa122-8225-48bf-9e38-35f3dfcd2ece 38 fields · synced May 31, 2026