CD HORIZON Growth Rod Conversion Set
FDA 510(k) clearance K150200 · decided 2015-02-25
Clearance details
- K-number
- K150200
- Device name
- CD HORIZON Growth Rod Conversion Set
- Applicant
- Medtronic Sofamor Danek USA, Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2015-01-29
- Decision date
- 2015-02-25
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- PGM
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic Sofamor Danek USA
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.