SOLSTICE OCT System
by Life Spine, Inc. 3 variants
510(k) K150229
SOLSTICE OCT System is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K150229 on 7 Apr 2015, 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 | NumberK150229 | Date7 Apr 2015 | StatusActive |
Official records
- FDA 510(k) database K150229
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K150229
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.
Similar devices
Other devices filed under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal).
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