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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K010246
Device Name KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A
Applicant
Kyphon, Inc.
1350 Bordeaux Dr.
Sunnyvale,  CA  94089
Applicant Contact KAREN TALMADGE
Correspondent
Kyphon, Inc.
1350 Bordeaux Dr.
Sunnyvale,  CA  94089
Correspondent Contact KAREN TALMADGE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/26/2001
Decision Date 02/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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