Device Classification Name |
Intervertebral Fusion Device With Bone Graft, Lumbar
|
510(k) Number |
K090064 |
Device Name |
EMINENT SPINE INTERBODY FUSION SYSTEM |
Applicant |
EMINENT SPINE |
16001 RONALD REAGAN BLVD. |
LEANDER,
TX
78641
|
|
Applicant Contact |
DAVE FREEHILL |
Correspondent |
EMINENT SPINE |
16001 RONALD REAGAN BLVD. |
LEANDER,
TX
78641
|
|
Correspondent Contact |
DAVE FREEHILL |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/09/2009 |
Decision Date | 04/09/2009 |
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
|
|
|