Identity
- Trade Name
- Vertecem II Cement Kit FDA UDI
- Generic Name
- Vertebral bone filler, non-bioabsorbable FDA UDI
- Device Name
- Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure. FDA UDI
- Model / Reference
- 08.702.017S FDA UDI
- Description
- Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure. FDA UDI
Identifiers
- Catalog Number
- 08.702.017S FDA UDI
- Primary DI / UDI-DI
- 04260056880759 FDA UDI
- FDA Product Code
- NDN FDA UDILOD FDA UDI
- GMDN Term
- Vertebral bone filler, non-bioabsorbable 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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 22 Gram FDA UDI
Category: Vertebral bone filler, non-bioabsorbable
Vertecem II Cement Kit by OSARTIS GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- OSARTIS GmbH
Sources (1)
- FDA UDI c39685df-bd2f-4d59-a0b8-a22319c3f060 36 fields · synced May 30, 2026