IntraOp Alignment System
by Alphatec Spine, Inc. 2 variants
510(k) K240199
IntraOp Alignment System is a medical device (FDA Class II; FDA product code OWB, Interventional Fluoroscopic X-Ray System) made by Alphatec Spine, Inc., cleared under FDA 510(k) K240199 on 22 May 2024, 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 | NumberK240199 | Date22 May 2024 | StatusActive |
Official records
- FDA 510(k) database K240199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K240199
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 | |||
|---|---|---|---|---|
| IntraOp Alignment System 505-410410 | 505-410410 | 00190376601182 | — | On the market |
| IntraOp Alignment System AIX4104 | AIX4104 | 00190376525921 | — | On the market |
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