The Acumed Wrist Fixation System - 2.4mm Screws
FDA 510(k) clearance K252356 · decided 2025-08-21
Clearance details
- K-number
- K252356
- Device name
- The Acumed Wrist Fixation System - 2.4mm Screws
- Applicant
- Acumed, LLC
- Decision
- Substantially Equivalent
- Date received
- 2025-07-29
- Decision date
- 2025-08-21
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hillsboro, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Acumed
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.