510(k) clearance
Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine
- 510(k) number
- K262257
- Applicant
- Brainlab SE
- Decision date
- Sep 30, 2026
- Date received
- Jul 2, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OLO
- Device type
- Orthopedic Stereotaxic Instrument
- Device class
- Class II
- Regulation
- 21 CFR 882.4560
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Munich, DE