K242361
- 510(k) number
- K242361
- Device name
- OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI
- Applicant
- Stryker Spine NJ · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2024-11-07
- Date received
- 2024-08-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242361.pdf
Official FDA record: K242361
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.