FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
K Number: K172269
·
Decision Mar 27, 2018
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
18
Applicant Total
172
Review Days
242
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Basic Information
- Device Name
- FORTRESS Radiopaque Bone Cement (FORTRESS and FORTRESS-Plus), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
- K Number
- K172269
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- July 28, 2017
- Decision Date
- March 27, 2018
- Product Code
- PML
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
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