510(k) clearance
Primal K-Wire (P99-193-1410)
- 510(k) number
- K262722
- Applicant
- Paragon 28, Inc.
- Decision date
- Aug 28, 2026
- Date received
- Jul 31, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- HTY
- Device type
- Pin, Fixation, Smooth
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Centennial, CO, US