SCRIPT™ Implant System
510(k) K253401
SCRIPT™ Implant System is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K253401 on 29 Apr 2026, active as of 25 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK253401 | Date29 Apr 2026 | StatusActive |
Official records
- FDA 510(k) database K253401
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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