Ion-L
510(k) K261209
Ion-L is a device classified as Unclassified made by Surgentec LLC, cleared under FDA 510(k) K261209 on 11 Jun 2026, 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 | NumberK261209 | Date11 Jun 2026 | StatusActive |
Official records
- FDA 510(k) database K261209
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MRW
- FDA applicant
- SurGenTec, LLC
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K261209
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ION 55 Facet Implant - Sterile TI-K-55 | TI-K-55 | 00810131881801 | On the market | |
| ION 60 Facet Implant - Sterile TI-K-60 | TI-K-60 | 00810131881818 | On the market | |
| ION 65 Facet Implant - Sterile TI-K-65 | TI-K-65 | 00810131881825 | On the market | |
| ION Disposable Instrument Kit TI-K-1000 | TI-K-1000 | 00810131881795 | On the market | |
| ION Non Cervical SR17-1000 | SR17-1000 | 00810131885045 | On the market |
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