Identity
- Trade Name
- MaxFuse PEEK VBR SYSTEM FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- MAXFUSE, 14.5x17x4042 REPLICA TRL SPACER FDA UDI
- Model / Reference
- 724-905 FDA UDI
- Description
- MAXFUSE, 14.5x17x4042 REPLICA TRL SPACER FDA UDI
Identifiers
- Catalog Number
- 724-905 FDA UDI
- Primary DI / UDI-DI
- 00191083015668 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 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
MaxFuse PEEK VBR 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 a2703cc7-6cfb-4fdd-b5f9-04b608b96327 36 fields · synced Jun 8, 2026