510(k) clearance
OsteoCoil™ GT Active Compression System
- 510(k) number
- K260106
- Applicant
- Flower Orthopedics Corporation DBA Conventus Flower Orthoped
- Decision date
- Aug 24, 2026
- Date received
- Jan 14, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HWC
- Device type
- Screw, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3040
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Horsham, PA, US