Identity
- Trade Name
- SLIMFUSE ANTERIOR CERVICAL PLATE SYSTEM FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- MODULAR DRILL FDA UDI
- Model / Reference
- 21-MODRILL-12 FDA UDI
- Description
- MODULAR DRILL FDA UDI
Identifiers
- Catalog Number
- 21-MODRILL-12 FDA UDI
- Primary DI / UDI-DI
- 00846468003531 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
Slimfuse 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 6f32023a-1087-4bb2-8cc4-e7a5d346d11a 36 fields · synced Jun 8, 2026