Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
FDA 510(k) clearance K161318 · decided 2017-03-20
Clearance details
- K-number
- K161318
- Device name
- Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
- Applicant
- Tedan Surgical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-05-11
- Decision date
- 2017-03-20
- Days to decision
- 313 days
- Clearance type
- Traditional
- Product code
- GZT
- Device class
- 2
- Regulation number
- 882.4800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sugar Land, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tedan Surgical Innovations
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.