Identity
- Trade Name
- XIPHOS ZFUZE FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- TLIF Spacer 30mm Long x 13mm Height FDA UDI
- Model / Reference
- ZF-300-3013 FDA UDI
- Description
- TLIF Spacer 30mm Long x 13mm Height FDA UDI
Identifiers
- Catalog Number
- ZF-300-3013 FDA UDI
- Primary DI / UDI-DI
- 00853896008342 FDA UDI
- 510(k) Number
- K190544 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Interspinous spinal fixation implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Interspinous spinal fixation implant
Xiphos Zfuze by Difusion Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Interspinous spinal fixation implant.
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
- Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
- InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II
Cleared under the same submission
K190544 also covers:
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
- XIPHOS ZFUZE — Difusion Technologies
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
- Difusion Technologies
Sources (1)
- FDA UDI 5cebd818-90b8-40a8-bff1-ebcbe9d25b3c 37 fields · synced May 30, 2026