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 Number | 888.1100
|
Classification Product Code |
|
Date Received | 01/26/2001 |
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
|
Recalls |
CDRH Recalls
|
|
|