FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCRIPT Implant System
K Number: K253401
·
Decision Apr 29, 2026
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
172
Review Days
211
Basic Information
- Device Name
- SCRIPT Implant System
- K Number
- K253401
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Globus Medical, Inc.
- Date Received
- September 30, 2025
- Decision Date
- April 29, 2026
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
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| K Number | Device Name | ||
|---|---|---|---|
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| K250599 | ExcelsiusGPS Instruments | Nov 5, 2025 | Substantially Equivalent |
| K251161 | ANTHEM® Fracture System | Aug 18, 2025 | Substantially Equivalent |
| K241525 | ExcelsiusXR | Jul 8, 2025 | Substantially Equivalent |
| K243456 | ONVOY Acetabular System | Jun 6, 2025 | Substantially Equivalent |
| K243814 | NuVasive Pulse System | Jan 10, 2025 | Substantially Equivalent |
| K243671 | ExcelsiusGPS® Instruments | Dec 20, 2024 | Substantially Equivalent |