Guided DAS Surgical Kit
FDA 510(k) clearance K243425 · decided 2025-07-22
Clearance details
- K-number
- K243425
- Device name
- Guided DAS Surgical Kit
- Applicant
- Talladium España, SL
- Decision
- Substantially Equivalent
- Date received
- 2024-11-04
- Decision date
- 2025-07-22
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lleida, ES
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Talladium España
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.