HKT Anatomical Locking Trauma System
FDA 510(k) clearance K254249 · decided 2026-02-27
Clearance details
- K-number
- K254249
- Device name
- HKT Anatomical Locking Trauma System
- Applicant
- Hankil Tech Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-29
- Decision date
- 2026-02-27
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hwaseong-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.