PINNACLETM Constrained Acetabular Liners
FDA 510(k) clearance K240639 · decided 2024-04-04
Clearance details
- K-number
- K240639
- Device name
- PINNACLETM Constrained Acetabular Liners
- Applicant
- Depuy Ireland UC
- Decision
- Substantially Equivalent
- Date received
- 2024-03-06
- Decision date
- 2024-04-04
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- KWZ
- Device class
- 2
- Regulation number
- 888.3310
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Cork, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy Ireland UC
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.