FDA Registration Active 🇺🇸 United States

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Reg #: 3010663372 · FEI: 3010663372 · Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1

Registration Details

Registration Name
DEGEN MEDICAL
Registration Number
3010663372
FEI Number
3010663372
Status
Active
Expiry Year
2025
Initial Importer
No
Address
1321C N Cashua Dr
City
Florence
State
SC
ZIP
29501
Country
US

Regulatory Submissions

510(k) Number
K150759

Owner / Operator

Firm Name
DeGen Medical
Operator Number
10048016
Address
1321-C North Cashua Drive
City
Florence
State
SC
Postal Code
29501
Country
US
Correspondent
Craig Black

Products

Device Name Product Code
Appliance, Fixation, Spinal Intervertebral Body KWQ

Proprietary Names

Hyper-C

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility