Spinal Injection System
510(k) K083909
Spinal Injection System is a Class II device made by Laurimed, LLC, cleared under FDA 510(k) K083909 on 18 Mar 2009, active as of 22 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 | NumberK083909 | Date18 Mar 2009 | StatusActive |
Official records
- FDA 510(k) database K083909
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- BSP
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5150
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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