STAXX(R) IB SYSTEM
FDA 510(k) clearance K123461 · decided 2013-04-11
Clearance details
- K-number
- K123461
- Device name
- STAXX(R) IB SYSTEM
- Applicant
- Spine Wave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-09
- Decision date
- 2013-04-11
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spine Wave
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
| Record | Firm | Date |
|---|---|---|
| StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; recall (Z-2187-2013) | Spine Wave, Inc. | 2013-09-11 |