Atlas FDA

KYPHON EXPRESS II INFLATABLE BONE TAMPS

FDA 510(k) clearance K123771 · decided 2012-12-21

Clearance details

K-number
K123771
Device name
KYPHON EXPRESS II INFLATABLE BONE TAMPS
Applicant
Medtronic
Decision
Substantially Equivalent
Date received
2012-12-07
Decision date
2012-12-21
Days to decision
14 days
Clearance type
Special
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

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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HeartWare HVAD System (P100047/S227)Medtronic2025-07-09
HeartWare­™ Ventricular Assist System (HVAD) (P100047/S230)Medtronic2025-06-26
HeartWare™ Ventricular Assist System (HVAD) (P100047/S229)Medtronic2025-06-05
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228)Medtronic2025-06-04
HeartWare HVAD System (P100047/S226)Medtronic2025-05-05
HeartWare® HVAD System (P100047/S225)Medtronic2025-04-24
HeartWare HVAD System (P100047/S224)Medtronic2025-04-02
HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222)Medtronic2025-03-13