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C-Fuse® Cervical Intervertebral Body Fusion System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- C-Fuse® Cervical Intervertebral Body Fusion System FDA UDI
- Generic Name
- Surgical mallet FDA UDI
- Device Name
- Mallet FDA UDI
- Model / Reference
- MA-665 FDA UDI
- Description
- Mallet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815351021778 FDA UDI
- 510(k) Number
- K130948 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Surgical mallet 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
No
FDA UDI
Single Use
No
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
No
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
Category: Surgical mallet
C-Fuse® Cervical Intervertebral Body Fusion System by Southern Spine LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K130948 also covers:
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
- C-Fuse® Cervical Intervertebral Body Fusion System — Southern Spine LLC
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
- Southern Spine LLC
Sources (1)
- FDA UDI 6dfd289e-ab45-4883-b065-86e93aeb6528 35 fields · synced Jun 8, 2026