KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
FDA 510(k) clearance K041454 · decided 2004-07-09
Clearance details
- K-number
- K041454
- Device name
- KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
- Applicant
- Kyphon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-01
- Decision date
- 2004-07-09
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kyphon
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 |
|---|---|---|
| Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System recall (Z-3175-2011) | Medtronic Spine LLC (formerly Kyphon Inc.) | 2011-09-09 |
| KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon recall (Z-1209-2009) | Medtronic Spine LLC, formerly Kyphon Inc | 2009-05-11 |