Identity
- Trade Name
- AVAflex FDA UDI
- Generic Name
- Balloon kyphoplasty kit FDA UDI
- Device Name
- 10 gauge 30mm AVAflex Vertebral Balloon System FDA UDI
- Model / Reference
- 1031030000 FDA UDI
- Description
- 10 gauge 30mm AVAflex Vertebral Balloon System FDA UDI
Identifiers
- Catalog Number
- 1031030000 FDA UDI
- Primary DI / UDI-DI
- 07613327374599 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
- 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
Yes
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 — 10.0 Gauge FDA UDI
Category: Balloon kyphoplasty kit
AVAflex by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Balloon kyphoplasty kit.
- TRACKER — GS Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class I
- MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD. · Class II
- Zavation — ZAVATION · Class II
- InflateFX™ Gen II Fracture Management — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- KMC Double Balloon Assembly, 8 Gauge, 20mm — Shanghai Kinetic Medical Co., Ltd. · Class II
- Zavation — ZAVATION · Class II
- SYNTH™ PLUS — IMEDICOM CO., LTD. · Class II
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
- Stryker Corp.
Sources (1)
- FDA UDI 1c304b7b-9c50-489a-a54c-63e352d58e66 37 fields · synced May 30, 2026