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C-Fuse® Cervical Intervertebral Body Fusion System

FDA UDI

Class II (US FDA UDI)

by Southern Spine LLC

Identity

Trade Name
C-Fuse® Cervical Intervertebral Body Fusion System FDA UDI
Generic Name
Bone file/rasp, manual, reusable FDA UDI
Device Name
Rasp FDA UDI
Model / Reference
RA-660 FDA UDI
Description
Rasp FDA UDI

Identifiers

Primary DI / UDI-DI
00815351021761 FDA UDI
510(k) Number
K130948 FDA UDI
FDA Product Code
ODP FDA UDI
GMDN Term
Bone file/rasp, manual, reusable 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone file/rasp, manual, reusable

C-Fuse® Cervical Intervertebral Body Fusion System by Southern Spine LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone file/rasp, manual, reusable.

Cleared under the same submission

K130948 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Southern Spine LLC

Sources (1)

  • FDA UDI 9554afaf-9021-48ee-b264-6319ecdc32e5 35 fields · synced Jun 1, 2026