Identity
- Trade Name
- obelisc™ vertebral body replacement FDA UDI
- Generic Name
- Vertebral body prosthesis FDA UDI
- Device Name
- obelisc locking screw short, hex 3.5 mm FDA UDI
- Model / Reference
- CS 2901-01 FDA UDI
- Description
- obelisc locking screw short, hex 3.5 mm FDA UDI
Identifiers
- Catalog Number
- CS 2901-01 FDA UDI
- Primary DI / UDI-DI
- 04052536113699 FDA UDI
- 510(k) Number
- K060416 FDA UDI
- FDA Product Code
- MQP FDA UDI
- GMDN Term
- Vertebral body prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
obelisc™ vertebral body replacement by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K060416 also covers:
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obeliscPRO™ vertebral body replacement — Ulrich GmbH & Co. KG
- obelisc™ vertebral body replacement — Ulrich GmbH & Co. KG
- obelisc™ vertebral body replacement — Ulrich GmbH & Co. KG
- obelisc™ vertebral body replacement — Ulrich GmbH & Co. KG
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
- Ulrich GmbH & Co. KG
Sources (1)
- FDA UDI a7a4edbe-82bb-44e4-ad06-0f0e3ac1ce18 37 fields · synced Jun 8, 2026