Identity
- Trade Name
- TOSCA FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- The TOSCA Anterior Cervical Plate System consits of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine through the anterior approach. The plates and screws are made from Titanium alloy Ti6Al4V, are in conformance with ASTM F136, and are supplied non-sterile. FDA UDI
- Model / Reference
- Connection screw FDA UDI
- Description
- The TOSCA Anterior Cervical Plate System consits of various sizes of bone plates and screws that are either fixed angle or variable angle. The screws are used to secure the plates to the vertebral bodies of the cervical spine through the anterior approach. The plates and screws are made from Titanium alloy Ti6Al4V, are in conformance with ASTM F136, and are supplied non-sterile. FDA UDI
Identifiers
- Catalog Number
- ATM309T FDA UDI
- Primary DI / UDI-DI
- 04047844005965 FDA UDI
- 510(k) Number
- K082848 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
Tosca by SIGNUS Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
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- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K082848 also covers:
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- NUBIC — SIGNUS Medizintechnik GmbH
- RABEA 0° — SIGNUS Medizintechnik GmbH
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
- SIGNUS Medizintechnik GmbH
Sources (1)
- FDA UDI 278c48e5-0b70-46c1-b9d2-333a238e540e 38 fields · synced May 30, 2026