RAMPART-L
FDA 510(k) clearance K133371 · decided 2014-01-09
Clearance details
- K-number
- K133371
- Device name
- RAMPART-L
- Applicant
- Spineology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-01
- Decision date
- 2014-01-09
- Days to decision
- 69 days
- Clearance type
- Special
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spineology
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.