Identity
- Trade Name
- CervAlign Anterior Cervical Plate System FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Modular Tap FDA UDI
- Model / Reference
- 66-MODTAP-10 FDA UDI
- Description
- Modular Tap FDA UDI
Identifiers
- Catalog Number
- 66-MODTAP-10 FDA UDI
- Primary DI / UDI-DI
- 00846468088187 FDA UDI
- FDA Product Code
- HWX FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
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
CervAlign Anterior Cervical Plate System by Pioneer Surgical Technology, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI b4aaf858-35c5-4450-aa0c-0ea88615fa4c 37 fields · synced Jun 6, 2026