Device Classification Name |
Fastener, Fixation, Biodegradable, Soft Tissue
|
510(k) Number |
K002020 |
Device Name |
LACTOSORB MENISCAL SCREW |
Applicant |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
WARSAW,
IN
46581 -0587
|
|
Applicant Contact |
MARY VERSTYNEN |
Correspondent |
BIOMET MANUFACTURING, INC. |
56 EAST BELL DR. |
WARSAW,
IN
46581 -0587
|
|
Correspondent Contact |
MARY VERSTYNEN |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 07/03/2000 |
Decision Date | 08/25/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|