Device Classification Name |
Cement, Bone, Vertebroplasty
|
510(k) Number |
K060300 |
Device Name |
CONFIDENCE HIGH VISCOSITY BONE CEMENT |
Applicant |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
11 HA'HOSHLIM ST. |
HERZLIYA,
IL
46724
|
|
Applicant Contact |
HILA WACHSLER-AVRAHAMI |
Correspondent |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
11 HA'HOSHLIM ST. |
HERZLIYA,
IL
46724
|
|
Correspondent Contact |
HILA WACHSLER-AVRAHAMI |
Regulation Number | 888.3027
|
Classification Product Code |
|
Date Received | 02/06/2006 |
Decision Date | 06/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|