510(k) clearance
Duet™ Spinal Fixation System
- 510(k) number
- K262712
- Applicant
- Duet Spine Holdings, LLC
- Decision date
- Sep 30, 2026
- Date received
- Jul 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- NKB
- Device type
- Thoracolumbosacral Pedicle Screw System
- Device class
- Class II
- Regulation
- 21 CFR 888.3070
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Winona Lake, IN, US