Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K041989 |
Device Name |
SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X |
Applicant |
SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L |
MIAMI BEACH,
FL
33139
|
|
Applicant Contact |
ISABELLA ELIAS |
Correspondent |
SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L |
MIAMI BEACH,
FL
33139
|
|
Correspondent Contact |
ISABELLA ELIAS |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 07/23/2004 |
Decision Date | 09/16/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|