Vertical Expandable Prosthetic Titanium Rib
FDA 510(k) clearance K142587 · decided 2014-11-18
Clearance details
- K-number
- K142587
- Device name
- Vertical Expandable Prosthetic Titanium Rib
- Applicant
- Depuy Synthes Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-09-15
- Decision date
- 2014-11-18
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- MDI
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Depuy Synthes Spine
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.
| Record | Firm | Date |
|---|---|---|
| RESPONSE™ Rib and Pelvic System (K233105) | OrthoPediatrics Corp. | 2024-01-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal r recall (Z-2488-2015) | Synthes (USA) Products LLC | 2015-08-31 |