Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K142230 |
Device Name |
Apollo Suture Anchor System and Titan Screws |
Applicant |
Valeris Medical |
200 Cobb Pkw N,Bldg 200 Ste 210 |
Marietta,
GA
30062
|
|
Applicant Contact |
Daniel Lanois |
Correspondent |
Wagoner Consulting LLC |
P O Box 15729 |
Wilmington,
NC
28408
|
|
Correspondent Contact |
Cheryl L Wagoner |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 08/13/2014 |
Decision Date | 09/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|